CSL

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

The Commissioning & Qualification Center of Excellence (CoE) Subject Matter Expert (SME) role leads the organization in the development and implementation of engineering procedures, standards and templates library to ensure reliability and compliance with company policies and government regulatory requirements for facilities, utilities, equipment, analytical equipment and computerized manufacturing systems through the definition, planning, and execution of Commissioning & Qualification activities in projects and routine manufacturing operations. The C&Q CoE SME takes a proactive role in supporting projects and providing support by building a high level of trust with internal and external stakeholders. Your responsibilities: Preparation and execution of CQV life cycle deliverables, project plans, URS/DQ/RTM/Risk Assessments/commissioning test plans/IOQ/PQ/Final reports.Collaborate with the Computerized System Validation team for the delivery of integrated testing for manufacturing computerized systems. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 compliance and latest industry expectations for data integrity.Provide Peer Review for key project designs.Coordinate external contracted project resources and third parties/vendors for the flawless execution of Commissioning and Qualification projects activities, as needed.Review of CQV deliverables generated by project team members.Effectively interfacing and communicating with 3rd parties, client and CQV project teams.Review the technical content in the C&Q sections of regulatory dossiers.Support Sites with Internal and External cGxP Audit Findings. Act as Point of Contact.Point of contact for program-specific regulatory inspection.Maintains global expertise through ongoing training and participation in industry forums.Assist the C&Q Strategy Lead in the delivery and project management processes required to complete projects within timeline and budget.Integrate CQV into the project lifecycle, working with other disciplines, both internal and external. Your profile: BS degree in engineering, life sciences or other related technical field, combined with 5 years (or MS plus 2 years) working experience in commissioning and qualification in a regulated industry (i.e., GxP manufacturing / research and development) with a broad-based understanding of pharmaceutical manufacturing and overall business processes.Good communication and conflict management skills to influence technical experts and stakeholders at all levels in the organization.Significant commissioning and qualification experience in Pharmaceutical /R&D projects.Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment.Working understanding of lean processes principles.Comprehension of Industry and Regulatory Authorities Regulations related toBiopharmaceutical Facilities including FDA, EMA, ICH, ASTM, ISPE, TGA,Excellent planning, organizing, analysis and problem-solving skills.Strong background and understanding in the planning and execution of projects.Demonstrated business acumen, understanding of business needs, risks and regulatory implications in the development/assessment of design alternativesAbility to work in a fast-paced environment, organized and able to prioritize tasks to meet multiple deadlines.Ability to use discretion with sensitive/confidential information.Demonstrated proficiency with standard Project Management tools (MS Project, Excel, Visio, SharePoint, PowerPoint) and templates.Excellent interpersonal, verbal and written communication skills.Excellent interpersonal skills with experience dealing with a diverse workforce.Experience in Heating ventilation and air condition (HVAC) a strong asset. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

General Description Tests, calibrates, and repairs electrical, mechanical, electromechanical, and electronic measuring, recording, and indicating instruments and equipment for conformance to established standards. Equipment will vary based on the business operations. Responsibilities: Establishes and maintains procedures to complete in-house calibrations. Maintains calibration database and records including generating reports. Assists in coordinating outside services to complete calibration activities. Provides technical support to all departments regarding the purchase of test equipment. Maintains records to ensure compliance to GxP requirements and supports internal/external audit of the calibration department. Assists engineering and interfaces with other departments concerning measuring and inspection activities when required. Responsible for tracking all calibrations electronically. Maintains the instrument and equipment calibration files. Performs routine calibrations for plant equipment, laboratory instruments, gauges, meters and other calibrated tools. Works with outside vendors to schedule and perform external calibrations. May write and revise calibration procedures for new plant instruments and equipment. Assists with the execution of new equipment qualification/validation studies and decommissioning activities for the site. Plans sequence of testing and calibration procedures for instruments and equipment. Prepares standard and special purpose laboratory equipment to test, evaluate, and calibrate other instruments and test equipment. Disassembles instruments and equipment and inspects components for defects. Repairs or replaces components as needed. Procures spare parts for repairs and maintains spare parts inventory to support instrumentation and electrical requirements. Reassembles and calibrates instruments and equipment. Maintains accurate and up-to-date calibration records. Uses company-provided software to document all calibration and repair activities. Enters new equipment information into the master schedule to ensure files are created and routine calibration work orders are created prior to the expiration of calibration. Must be capable of operating a personal computer (PC), familiar with Windows formatted software, and sufficiently familiar with computer operations. SAP PM experience is preferred. Perform other job-related duties as assigned. This is an off-shift position: will cover night shift. This position requires occasional weekends (throughout the year) and holiday work (generally around shutdown periods scheduled for July and Dec/Jan). Qualifications: -Associate degree and/or Technical Degree or Certification is required (or completing) -1-2 years' related experience including experience in a regulated environment -Equivalent combination of education and experience -Possesses strong technical aptitude -Demonstrated problem solving skills -Performs work independently with minimal supervision and with integrity -Excellent collaboration and team building skills -Knowledge of cGMP standards -Proficiency in Microsoft Office and QA systems Work Conditions -Fast paced environment with frequent interruptions -Required to lift and move up to 50 lbs. -Sitting, walking and standing frequently -Use hands to reach, finger, handle or feel objects, tools or controls -Exposure to moving mechanical parts, vibration and/or moderate noise levels -Shares information with external contacts with common desire to reach a solution -Understands complex problems to collaborate and explore alternative solutions -Ability to make decisions which have significant impact on the department’s creditability, operat-ions and services -Ability to compose letters, outlines, memorandum and basic reports and/or to orally communicate technical information -Ability to compute, analyze and interpret numerical data for reporting purposes -Frequently exposed to extreme temperatures temperatures(2-80C and 40oC), Steam, 800C+ Water Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Für die Abteilung Qualitätssicherung CSL Plasma GmbH in Göttingen suchen wir ab sofort einen Mitarbeiter in der Qualitätssicherung als GMP-Koordinator (m/w/d) (Vollzeit unbefristet) Verantwortungsbereich: Unterstützung des Senior GMP Koordinators in Überwachung und Koordination zur Sicherstellung der GMP-Compliance durch: Erstellung und Pflege von Schulungsprofilen und Überwachung des Trainingsstandes des Teams in der Funktion der/des Schulungsbeauftragten;Unterstützung bei Erstellung, Überarbeitung und Verwaltung von Qualitätsvereinbarungen einschließlich Spezifikationen für die Herstellung von Plasma zur Fraktionierung.Betreuung diverser bestehender sowie Implementierung neuer QA-Systeme in der Abteilung und turnusmäßiger Benutzerreview;Monatliche Erstellung von qualitätsrelevanten Kennzahlen und Pflege der Statistik für die Abteilung;Verantwortlich für die Überwachung der Einhaltung firmeninterner Kennzahlen (wie z.B. für Abweichungen und CAPA-Maßnahmen)Koordination und Nachverfolgung der Bearbeitung von Standardarbeitsanweisungen im elektronischen DokumentenmanagementsystemLiteraturrecherche im Bereich EU-GMP-Richtlinien / EU Verordnungen / Regularien und Gesetze im Bereich Plasmagewinnung und Verarbeitung Deine Erfahrung: Erfolgreich abgeschlossene kfm. oder techn. Berufsausbildung, 1-3Jährige Berufserfahrung (vorzugsweise im Gesundheits- und/oder Qualitätssicherungswesen) oder abgeschlossenes Bachelorstudium in Business Administration oder im naturwissenschaftlichen BereichHohes Qualitätsbewusstsein/GxP-gerechtes ArbeitenAnalytisches und vorausschauendes DenkvermögenAusgeprägtes Verständnis für Zahlen und gute Kenntnisse in der Erstellung von Statistiken/ExceltabellenSehr gute Kenntnisse des Microsoft Office Pakets (Excel, Word, Powerpoint, Outlook)Sehr gute Ausdrucksweise in Wort und Schrift (Deutsch und Englisch verhandlungssicher)Strukturierte und selbständige ArbeitsweiseAusgeprägte Kommunikations- und MotivationsfähigkeitFlexibilität sowie Team- und KonfliktfähigkeitWeitere Fremdsprachenkenntnisse wünschenswert Benefits: Abwechslungsreiches sowie anspruchs- und verantwortungsvolles AufgabengebietAngenehme Arbeitsatmosphäre in einem internationalen, dynamischen und leistungsstarken TeamMöglichkeiten zur persönlichen und beruflichen WeiterentwicklungEine attraktive Vergütung mit zusätzlicher Altersversorgung Ihre aussagekräftige Bewerbung richten Sie bitte an: CSL Plasma GmbH, QA_SQ EMEA, Ute Cherfan, Weender Strasse 75 in 37073 Göttingen oder per Email an ute.cherfan@cslplasma.com Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

1 Responsible for maintaining quality oversight of implementation activities including but not limited to execution of implementation checklist action items, equipment management, supply management, document management and training. Troubleshooting implementation exceptions and making necessary adjustments to ensure an efficient and effective project implementation in plasma centers. 2 Provide quality compliance oversight of deployment team members and plasma centers involved in the implementation. Identify and manage issues of non-conformity including implementing containment and remedial actions, implementing corrective actions, ensuring appropriate documentation of non-conformance and determining effectiveness of these actions. Responsible for notification to the Assistant Manager of Quality Assurance, Innovation or Associate Director Operations and Quality, Innovation for any event that negatively affects the safety, quality, identity, purity or potency of the product that results in pausing or disruption of business. If necessary, notification may be elevated to any of the following, project leadership, Associate Director of QA, or Director Quality Assurance. 3 Monitor, track, and trend implementation activities to meet established milestones and deadlines. Makes decisions to resolve issues that may jeopardize the implementation process. Monitor, track and trend quality metrics for implementation. Provide reports and status updates on implementation progress and quality compliance to include metric and KPI information to manager, project team members, and project leadership. 4 Monitor implementation training and training assignments through the use of Plateau reports and/or other Plateau admin items. Support training of deployment team members and plasma center employees. 5 Support plasma center audits and inspections as related to project implementation activities by responding to inquiries and providing reports or attending inspections as requested. 6 Provide oversight of employee relation issues and will collaborate with Assistant Manager of Quality Assurance, Innovation. Adhere to all HR policies and practices through fair and equitable treatment of all employees. Communicates effectively with HR to ensure HR compliance. 7 Act as a liaison within a multi-layered project by transferring knowledge and sharing communication to other groups as needed. Shares information with external and internal contacts with common desire to reach a solution. Will be responsible for contacting company employees at multiple organizational levels to resolve implementation quality issues and provide implementation readiness updates. 8 Provide a model of good customer service to all employees. Collaborate with center leadership to ensure and provide excellent customer service. Communicate openly with employees and vendors. Effectively resolve complaints or concerns. 9 MTQ’s must be able to complete leadership development program and be able to relocate within 6-7 months of completion of the deployment short term assignment. 10 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 11 Follow all Standard Operating Procedures (SOPs), company policies and procedures. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 12 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 13 Maintain confidentiality of all personnel, donor and center information. 14 Perform other job-related duties as assigned. Education o Bachelor’s Degree preferred or equivalent combination or education and professional work experience required Experience o Minimum one (1) year of supervisory leadership experience to include responsibility for overseeing the activities of others o One (1) year Quality experience required or completion of CSL Plasma Leadership Development program o Must be proficient in Plateau administrative tasks and deviation/error management o Ability to interrupt implementation progress and/or status and remain agile to adjust overall objectives o Ability to lead staff without direct authority, which includes providing feedback, giving direction, and holding other accountable for actions and results o Ability to keep others in remote locations on track to achieve company stated results o Must be proficient in Word, Excel, PowerPoint, and email applications Additional Comments o Bilingual skills a plus o Requires solid written communication skills in standard business language for composing and editing correspondence o Proficient in English language o Proficient in MS Office o Strong organizational skills motivated and self-starter o Able to take initiative and react quickly and with precision to urgent situations o Requires working with in restrictive confidential projects to support overall CSL strategy o Strong background in document control o Strong background in the equipment validation process (including, but not limited to, failed o validations) Working Conditions (physical & mental requirements) o Shares information with external and internal contacts with common desire to reach a solution o Ability to make decisions which have significant impact on the department’s creditability, operations, and service o Ability to formulate complex and comprehensive materials such as authoritative reports of major scope and impact and/or develop presentations o Occasionally perform tasks while standing and walking up to 100% of the time o Reach, bend, kneel and have a high level of manual dexterity o Overnight travel required greater than 80% of the time o Ability to lift and carry up to 30 lbs. o Required to wear Personal Protective Equipment while performing specific tasks to prevent exposure of blood borne pathogens o Ability to make decisions which have significant impact on the immediate work unit o Attention to detail and ability to follow written and verbal directions required o Extended work hours and weekends may be required o Fast paced environment with frequent interruptions Note: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Zur Verstärkung unseres Qualitätsteams in St. Gallen suchen wir derzeit eine(n) SachbearbeiterIn GxP Quality Systems für einen befristeten Vertrag (12 Monate). In dieser Position berichten Sie direkt an den Leiter des Qualitätsmanagementsystems. Wir bieten ein flexibles und hybrides Arbeitsmodell an. (#LI-Hybrid) Hauptaufgaben Administrative Unterstützung der Quality-Systeme Pflege von Daten in diversen Systemen (z.B. eDocument Management System, Trackwise, Learning Management System) Nachverfolgung von Massnahmen mit diversen Abteilungen (innerhalb und ausserhalb von Quality) Mitarbeit in Quality Projekten (z.B. Transfer von Dokumenten, Wechsel von Systemen) Archivierung von Dokumenten Unterstützung bei der Erstellung von Trainingsmaterialien, Standard-Arbeitsanweisungen (SOPs), usw Qualifikationen Die Kenntnisse und Fähigkeiten, die zur Erfüllung der Aufgaben dieser Position erforderlich sind, werden in der Regel durch die folgende Kombination aus Ausbildung, Erfahrung und Wissen oder einem Äquivalent erworben. Mindestanforderungen: Abgeschlossene Berufslehre im Bereich Kaufmännischer Angestellte/r, Laborant/in oder ähnliches Bereitschaft neue Prozesse zu erlernen und umzusetzen Organisationstalent Genauigkeit Datenbankaffinität Deutsch sehr gut in Wort und Schrift Englisch gut in Wort und Schrift Erweiterte Anforderungen: GxP Erfahrung in pharmazeutischen Unternehmen About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB Please note, we may not have an immediate need at the present time; however we are always interested in speaking to well qualified candidates for future openings. If you are interested in exploring a career with CSL, please apply. Someone will follow up depending on the current needs, but please be aware correspondence may not be immediate. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

The Opportunity RELOCATION and TRAVEL REQUIRED CSL Plasma is one of the World's largest collectors of human plasma. Our work helps ensure that tens of thousands of people with rare and serious diseases live normal, healthy lives. CSL Plasma has 300+ collection centers in the U.S. Our Management Trainees are partnered with some of our most experienced, knowledgeable and passionate leaders across the fleet. The Role ​This is a 6 – 9 month accelerated training program, and offers professionals a Promising FUTURE with a clear career path. You can expect to receive development opportunities through live environment and classroom-style training, one-on-one mentoring, networking and travel opportunities. You will relocate with a promotion to Assistant Manager Quality at any one of CSL's plasma centers located within the states of Michigan, Indiana or Ohio after training is completed. Company paid relocation assistance provided. overnight travel up to 25% of time. You will report to the Assistant Manager Quality. Three Phases of the Management Trainee Program: 1. Production Training (6 weeks): You will learn staff responsibilities, including: Medical Reception Technician, Donor Support Technician, Phlebotomy and Plasma Processing Technician. 2. Center Leadership Training (10 – 14 weeks): You will travel overnight a total of 5 weeks to our leadership training sites (1 – 3 weeks at a time) to attend classroom style and live-environment training. 3. Leadership Experience & Development (12 weeks): You will receive weekly one-on-one mentoring with your Sponsor (mentor) and complete a series of leadership development classes. Some of your daily responsibilities will include: Trending and investigations of deviationsChange management and improvement plansProvide feedback to staff on observationsLead audits and ensure center is inspection-ready.After completing the three phases, you will be eligible to apply for a promotion. You will travel overnight to support other centers until promoted. Your Skills and Experience Education: Bachelor's degree or equivalent combination of education and professional work experience including 1 year supervisory or leadership experience. Your Benefits: Medical/Dental/Vision - (eligible on day one of employment)Maternity/Paternity LeaveShort and Long-term disabilityTuition assistance401(k) plan15 days of PTO4 personal holidays9 company holidays annuallyCSL Share Plan (15% Discount)Well-Being ProgramFinancial Advising & Legal ServicesAdoption Assistance Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Job Description Summary This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance with CSL Operating Procedures, as well as all applicable local, state, federal requirements. This role will ensure compliance to training needs, SOPs, processes and other regulatory or company directives are adhered in order to support the operations and quality requirements for business operations. • Reporting compliance status data to operational quality management • Collaborate with center management in the development and implementation of continuous improvement plans • Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during internal and external audits, responds to questions, and may stop operations, including shipments to address quality concerns • Responsible for coordinating and managing training activities, policies and processes at the center level ​Job Description 1 Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications. 2 Ensure center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 3 Perform center records QA review to ensure thoroughness, accuracy and timeliness of required information. Initiate investigation and ensure documentation of regulatory deficiencies. Determine the need for corrective action, ensure appropriate documentation and determine effectiveness of the action. 4 Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements. 5 Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards. 6 Initiates schedule, coordinate and monitor the delivery of all training, such as new hire, annual and any retraining to meet center or other training and regulatory requirements. Ensure the most current version of training materials at the center is being used 7 Collaborates with center management when viewing the Quality Management System to identify, coordinate and deliver retraining for the purpose of correcting or improving operational or quality issues. 8 Conduct periodic process assessments to ensure compliance of CSL written procedures. Initiate investigation to ensure documentation of deficiencies and development of corrective action plans, as necessary in partnership with management. 9 Identifying and communicate non-conformities to CSL’s SOP’s. In the absence of the AQM, may conduct monthly quality team meeting to inform, promote, assess and identify opportunities for continuous process improvement in quality, safety, and training for implementation. 10 Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center. 11 Conducts and may lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OHSA, FDA, and other regulations, as applicable, and develop center responses for deficiencies. In the absence of the AQM, host external audits conducted by the regulatory agencies and customers. 12 Responsible to initiate, investigate and close Trackwise reports in a timely manner. Confirm through follow-up, to ensure appropriate corrective action was initiated, implemented, and effective. 13 Maintain clean efficient work environment. Comply with all Health Safety and Environmental (HSE) and Occupational Safety and Health Administration (OSHA) policies and procedures. Conduct routine internal procedure and documentation audits, as applicable. 14 Follow all Standard Operating Procedures (SOPs), company policies and procedures. 15 Comply with all local, state and federal regulations and laws to include, but not limited to: ADA, Civil Rights, EEOC, FDA, GHA, HIPAA, and OSHA. 16 Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable. 17 Assist Plasma center staff in completing other special projects or assignments, as requested. 18 Perform other job-related duties, as assigned. Education • High school diploma or equivalent required. Associate or Bachelor’s degree in business administration or biological sciences preferred. Experience • Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment. • Strong customer service skills • Strong critical reasoning, decision-making and problem solving skills to analyze situations • Organizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives • Understand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) • Occasionally required to work with the public when they are dissatisfied • 80% of the time standing and walking and 20% of the time sitting • Reach, bend, kneel and have high level of manual dexterity • See and speak with customers and observe equipment operation • Occasionally be required to lift and carry 25 lbs. • Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, disability, veteran status, national origin or other legally protected classifications. #CB #CB CSL offers the following benefits for this full-time position, most are effective the first day of hire: Options for health care benefits, including choices of plans for medical and prescription drug, dental, and vision coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. Our BenefitsCSL offers the following benefits for this full-time position: Options for health care benefits, including choices of plans for medical, dental, and vision, prescription drug coverage; Company-provided basic life insurance and Short- and Long-Term Disability; the option to participate in CSL’s 401(k) Savings Program; Paid Time Off (PTO) for use in connection with vacations, illness, and other personal business; and paid observed holidays as designated by the Company. For more information on CSL Plasma benefits visit https://cslbenefits.com/cslp. About CSL PlasmaCSL Plasma is one of the world's largest collectors of human plasma. Our work helps to ensure that people with rare and serious diseases are able to live normal, healthy lives. We are committed to our work because lives depend on us. Learn more about CSL Plasma. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Plasma!

Responsibilities: • repsonsible for material/plasma/product release, including lot release realted job • support on the supplier audit and plasma center • manage relase cycle time. • reponsible for the material management and releated document update Qualifications: • Associate's degree in a relevant scientific discipline or equivalent vocational or technical training • 2-3 years' experience including experience in the QC or QA pharmaceutical manufacturing/a highly regulated industry • Proficiency in MS Office and other relevant software programs • Knowledge of cGMP standards Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Objectif du poste: Apporte une expertise scientifique et non promotionnelle sur les spécialités pharmaceutiques de CSL Behring aux professionnels de santé, avec lesquels il/ elle développe des relations privilégiées de façon à différencier CSL Behring Travaille avec les différents acteurs de l’entreprise afin d’assurer cette mission scientifique (information médicale, essais cliniques, partenariats scientifiques), et représente l’entreprise sur son secteur géographique Relaye la Direction des Affaires Médicales sur le terrain. Missions et Responsabilités : Apporter une expertise scientifique aux professionnels de santé : Maitriser de façon approfondie l’environnement médical des spécialités pharmaceutiques de CSL Behring (aire thérapeutique, profil des patients, parcours de soin, pratiques cliniques, spécialités pharmaceutiques concurrentes), ainsi que les données scientifiques concernant ces spécialités pharmaceutiques, et être l’interlocuteur scientifique privilégié du corps médical. Anticiper les tendances dans les aires thérapeutiques en lien avec les spécialités pharmaceutiques CSL Behring, analyser les leviers en termes de stratégie de traitement. Présenter les données scientifiques aux professionnels de santé. Répondre aux questions scientifiques des praticiens. Rencontrer, à leur demande, les praticiens afin de connaître leurs attentes, comprendre et lever leurs objections éventuelles à l’utilisation des spécialités pharmaceutiques de CSL Behring. Etre force de proposition pour les symposia régionaux ou Réunions Scientifiques en région (participer aux comités scientifiques pour définir le contenu des réunions). Concevoir, à la demande, et avec le Directeur des Affaires Médicales de la gamme concernée, des programmes de formation sur les spécialités pharmaceutiques CSL Behring (Bon Usage) à destination des professionnels de santé. Susciter / Aider à la publication de données scientifiques concernant les spécialités pharmaceutiques ou l’environnement des spécialités pharmaceutiques exploitées par CSL Behring SA. Développer des relations privilégiées avec les leaders régionaux et tout autre groupe impliqué dans ce domaine : Initier et maintenir des relations de confiance avec les parties prenantes identifiées dans ce domaine tels les KOLs régionaux, les futurs KOLs, et tout autre professionnel de santé (PDS) décisionnaire. Identifier, favoriser et accompagner les partenariats scientifiques dans le domaine de la recherche clinique et épidémiologique (Investigator Initiated Studies) avec les KOLs régionaux sur les spécialités pharmaceutiques CSL Behring. Développer, avec la Direction des Affaires Médicales, des relations de confiance avec les associations de professionnels de santé, les autorités régionales, les sociétés scientifiques et toute autre organisation, dans le but de renforcer l’image institutionnelle et scientifique de CSL Behring. Travailler avec les différents acteurs de l’entreprise afin d’assurer la mission scientifique qui lui a été confiée auprès du corps médical : Fournir l’aide scientifique nécessaire aux Responsables des Relations Hospitalières (RRH) et aux Responsables Grands Comptes (RGC) dans le strict respect de la Charte de l'Information Promotionnelle, des procédures internes et toute autre règle en vigueur. Participer aux événements régionaux, nationaux et internationaux pour développer des contacts et des réseaux, et promouvoir ainsi l’image scientifique de CSL Behring. Assurer la veille scientifique et concurrentielle sur les innovations et les concepts thérapeutiques nouveaux dans les domaines d'intervention du laboratoire. Participer à la formation continue des RRH et des RGC, à la demande de la Responsable de formation et en accord avec son responsable hiérarchique. Notifier dans les délais impartis les informations de pharmacovigilance et les réclamations qualité aux services concernés. Préparer son Plan Médical Régional en lien avec les objectifs médicaux définis pour la région. Suivre ce plan d’action, et en assurer le reporting auprès de la Direction des Affaires Médicales. Respecter dès qu’elles s’appliquent, les procédures CSL Behring France et CSL Global (notamment : système qualité, procédures de la Direction des Affaires Médicales, pharmacovigilance) Utiliser le système COMPASS ainsi que tout autre outil ou processus requis par la direction et destiné au partage de l’information. Relayer la Direction des Affaires Médicales sur le terrain : Communiquer ou interagir avec les médecins impliqués dans les projets mis en place par la Direction des Affaires Médicales (en particulier les investigateurs des études CSL Behring ou académiques). Discuter/ participer à la conception de projets médicaux proposés par les experts locaux. Soumettre ces projets au Directeur des Affaires Médicales de la gamme concernée, et discuter leur faisabilité en interne. Mettre en place et suivre les projets approuvés par la Direction des Affaires Médicales dans sa région. Participer à la mise en place et au suivi des études de développement CSL Behring. Préparer les lancements (nouvelles spécialités pharmaceutiques et/ ou extension d’indications), selon les instructions de la Direction des Affaires Médicales et avec les outils conçus par le Directeur des Affaires Médicales de la gamme concernée et initier les discussions préliminaires avec les professionnels de santé afin d’identifier le parcours patient. Organisation de réunions d'experts régionales autour des actualités médicales en lien avec l'environnement pathologique Initier et entretenir des relations professionnelles avec les PDS et leurs associations conformes à la réglementation, à la déontologie et aux règles internes à l’entreprise, notamment celles liées à la loi dite anti-cadeaux, à la loi sur le renforcement sanitaire du médicament et, concernant les données collectées, aux exigences applicables de la nouvelle loi 78-17 du 6 janvier 78 modifiée et du Réglement Général sur la Protection des Données (RGPD) Conditions d'admissibilité et expérience requise : Pharmacien ou Formation Scientifique > Bac +5 Expérience similaire d’au moins 3 ans (Responsable Médical Régional/ Médecin Régional) dans des domaines thérapeutiques complexes et hospitaliers ou Expérience de la Recherche Clinique en tant que Chef de Projet (10 ans minimum) Anglais : courant (lecture, présentation, participations à des congrès, contacts avec des équipes internationales) Bureautique : utilisation de PPT, Word et Excel Connaissances de la réglementation et de l’environnement de la santé : en particulier la réglementation régissant la pharmacovigilance, l’information médicale et les essais cliniques, ainsi que la Charte de l'Information Promotionnelle Parfaite connaissance de l’hôpital et de la recherche clinique académique ou privée Maîtrise de la lecture scientifique Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

The candidate is educated in medical-sciences and is a Medical Science Liaison with demonstrated experience in the field and with educating, coaching, and mentoring peers. With a highly effective level of proficiency, he/she will strategically identify, develop, and maintain educational materials as they relate to CSL’s marketed Immunology and Hematology products, pipeline agents and competitors for use to educate new colleagues and to advance and measure knowledge and skills of the Field Medical enterprise organization. Responsibilities: Create, execute, and continuously optimize a Medical education plan for all newly hired MSLs and Infusion Science Specialists(ISSs) and other skills & knowledge that advance performance of all colleagues. Work closely with FTLs, Medical Information, and CSL Learning & Growth colleagues to coordinate the development and necessary approval (MLR, PRC requirements) of all new Medical educational materials on the company's marketed Immunology, Hematology and other therapeutic areas within the pipeline products and disease states, as well as key competitors science and products. Work seamlessly with Field Medical Team Leaders (FTLs) with various projects and by educating, coaching, and mentoring team members that assists with their development plans. Leverage a variety of communication channels to provide education to a variety of adult learning styles. Skillfully plan and effectively deliver presentations and lead live and virtual educational sessions.Lead innovative initiatives in communication and training.Manage budgets and related administrative requirements related to curriculum development, training resources, and educational meeting implementation. Qualifications: Education: Doctoral or advanced level degree in a Medical and/or scientific field is required • Min. 7 years as a MSL with demonstrated peer education experience is required. • Min. 2-3 years of disease management and product knowledge therapeutic areas of interest to CSL Behring or a related therapeutic area is highly preferred. • Must have broad-based scientific and pharmaceutical knowledge, as well as excellent presentation, mentoring and teaching skills. • Must demonstrate strong overall written and verbal communication skills. • Has the ability to motivate and educate peers without a direct reporting relationship. • Demonstrates the ability to think critically, analyze situations and achieve goals. • Is skilled technologically, including power point, word & excel. • Has a thorough understanding of the pharmaceutical corporate environment. #LI-JG2 Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

CSL Vifor is a world leader in Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company, experiencing rapid growth due to pipeline realization and optimization. To support our growth, we are looking for a Medical Scientific Liaison (MSL) to join our organization in Romania and you will report to the MSL Manager. You will cover 1/3 of the country. The Medical Scientific Liaison (MSL) position represents Medical Affairs externally and is critical to establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), Health Care Professionals (HCPs) and key accounts on behalf of CSL Vifor. MSLs execute country medical plans locally by representing the medical expertise in CSL Vifor disease states and products and through scientific engagement with the medical community provide disease state education, medical information and research support. The current prioritized therapeutic areas are cardiology, nephrology and Patient Blood Management (PBM). Your responsibilities and tasks will be the following, but not limited to : * Develops and maintains medical and scientific expertise on pathologies and Vifor Pharma products * Identifies, develops, and maintains professional relationships with KOLs, HCPs and Professional Organizations * Establishes interactions/engagements with key opinion leaders, provides medical support, training, and other appropriate activities * Facilitates scientific engagement and medical information exchange with KOLs * Provides medical education regarding pathologies and clinical data, and responds to requests for medical information * Communicates to the medical team and other internal partners the scientific information obtained in interactions with the medical community * Provides medical support for patient access programs to Vifor Pharma products as well as (if applicable) for access through local review committees, following global and local policies and procedures. * Supports the development, implementation, and completion of medical activities (advisory boards, symposia at congresses, hospital level meetings and speaker programs) * Serves as a medical resource for internal medical training, including the sales team. * Supports company-sponsored clinical research as well as processes related to IIS type studies (independent investigator-initiated studies) * Participates in relevant scientific meetings and conferences and supports the development of key clinical data summaries, presentations, or symposia relevant to Vifor Pharma. * Ensures that all activities and interactions are conducted in compliance with applicable laws, regulations, local and global guidelines, as well as company policies and procedures. * Develops personal and professional qualities for the permanent improvement of professional skills and capabilities. * The MSL is expected to work closely with the Medical Representatives (Sales Team) and Marketing Department in the company. * The MSL is expected to follow scientific and clinical progress in specified therapeutic areas by means of literature, electronic media, international and national meetings and conferences. Minimum Requirements * University degree in Medical or Life Science Field (e.g. Medicine, Pharmacy, Biology/ Biochemistry) * Minimum of 3 years’ experience in clinical practice, research or pharmaceutical industry * Demonstrated experience in KOL, HCP or medical community engagement * Excellent oral and written communication skills in Romanian and good oral and written communication skills in English * Experience in public scientific presentations * Ability for overnight travel, up to 50% Preferred Requirements * Doctorate (MD, PhD, PharmD, etc.) or Master (equivalent) in the medical field (Pharmacy, Nursing) * Clinical and/or research experience in Cardiology, Surgery, Hematology, Anesthesiology, Nephrology, Internal Medicine * 5 years’ experience with pharma industry locally, regionally or globally * 3 years’ experience as MSL/Field Medical within pharmaceutical experience * Strong track record in KOL engagement * Experience in clinical research * Experience in literature review and analysis * Experience in planning and delivering Medical Trainings About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

CSL Vifor is currently undergoing unprecedented growth and portfolio expansion, in preparation for the imminent strengthening and diversification of our assets list, we are currently recruiting for a Launch Lead for our UK & Ireland affiliate. This is a truly unique opportunity to play a key role in the expansion and transformation of CSL Vifor. As a Launch Lead you will define strategy for new brands, communicate and align with all departments and their goals. The Launch Lead will develop and implement strategic and operational marketing plans which will deliver the desired levels of implementation and advocacy that we require. The role reports to the Head of Marketing and is based in Staines-upon-Thames (hybrid work). Your role and responsibilities will be the following: Tasks Build and effectively use customer insight as a basis for marketing strategy Gain approval for and effectively implement strategic and operational plans with appropriate budgets. Develop key message platforms for the brands and ensure they are effectively communicated to customers through scientific and commercial multi channels. Support the field teams by developing high quality, customer focused communication materials which align with the brand strategy. Monitor brand performance through a variety of qualitative and quantitative data sources and take appropriate action. Support market access activities as appropriate as part of cross –functional teams. Forecast sales and recommend Latest Estimates during the financial planning cycle. Manage forecasting for supply chain through an 18 month rolling forecast. Monitor and control expenditure within the marketing budget. Build external relationships with partners and customers. Build and maintain a high level of disease knowledge and credibility with physicians. Build effective and influential relationships with relevant HQ staff. Manage promotional activity within the appropriate Code of Practice. The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent. Minimum Requirements Scientific or Economics Degree Minimum 7 years’ experience in commercial functions with 3-5 years in a UK operational marketing role A track record of successful brand building, especially in the specialist medicine setting Demonstrable competence in all aspects of strategic and operational marketing including leading effective implementation A passion for brand building through insight, intelligence and evidence which turns ideas into results Proven track record of leading teams to outstanding sales achievement Experience with NHS funding and commissioning processes Basic understanding of medical aspects of therapeutic area along with willingness to develop in-depth expertise Professional level in English, both in oral and in written communications Excellent user of Office Programs (Word, Excel, PowerPoint) ABPI qualification Preferred Requirements Experience in VPUK therapeutic areas (Nephro, Gastro, COOP, Cardio) Experience of leading cross-functional teams in a matrix environment Ability to determine the appropriate course of business action to achieve company goals within diverse stakeholder agendas. Strong networking and stakeholder management skills Broad scientific, pharmacoeconomic and medical knowledge, with continuous expansion and learning ability. About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

CSL Vifor has a very exciting product pipeline in rare diseases. Therefore, in order to shape the landscape and prepare for launch, we are looking to expand our team of MSLs. We currently have a vacancy for an experienced Medical Science Liaison to be based in Jeddah. It is an exciting opportunity to be involved in a niche therapy area and be a part of a team launching a product in an area of unmet clinical need. Responsibilities: * As an MSL, you will be responsible for the following: * Develop and maintain scientific and medical expertise (Orphan disease areas) * Identify, develop and maintain relationships with KOLs, HCPs and professional organisations * KOL engagement, key account medical support, training and other appropriate activities * Facilitate scientific engagement, scientific exchange and medical information * Provide Disease State Education, clinical presentations and respond to medical requests * Update medical team and other internal stakeholders on medical community interactions * Provide medical support for patient and formulary access following global and local policies and procedures including liaison with patient associations * Support the development, implementation, and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs) * Serves as a medical resource for internal medical and sales training * Support company sponsored clinical research and IIS process * Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations, or symposium * Ensure compliance with applicable local and global laws, regulations, guidelines and company policies and procedures Requirements: As a Medical Science Liaison, you will need to demonstrate the following skills and experience: * Minimum of 3 years’ experience in clinical practice, research or pharmaceutical industry preferably in Nephrology, Rheumatology, Immunology and/or Rare Diseases * Demonstrated experience in KOL, HCP or medical community engagement * Experience in literature review and analysis * Experience in clinical research Excellent oral and written communication skills * Experience in public scientific presentations and experience in planning and delivering medical trainings * Experience gained in the pharmaceutical industry and a strong understanding of the healthcare compliance requirements locally and globally * Strong communication skills and fluency in Arabic and English Educational qualifications: * University degree in Medical or Life Science Field (e.g. Medicine, Pharmacy, Biology/ Biochemistry) * Availability to travel up to 50% of the time is a must. If this opportunity is of interest to you, please apply by submitting your application including your updated CV in English. About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!

Position Location: San Jose, CA Main Responsibilities and Accountabilities: Promote products and increase usage of products to select call points, including HCP’s, hospitals, hemophilia treatment centers, patient support groups, distributors and/or specialty pharmacies. Develops customer advocates for promoted products.Responsible for the development of new accounts and the growth of existing accounts through solid customer relationships, communication of technical product and disease state information, and effective territory management skills.Develop and implement territory business plans consistent with corporate direction designed to achieve/exceed territory sales targets. Appropriate knowledge of product features and benefits, competitive products and programs and distribution channels.Implement key marketing programs to increase market share of key promoted products. Maintain proper call frequency with assigned targets and update as needed to assure time is aligned with current product focus.Stay abreast of current clinical technical literature from medical journals and other information sources.Implement CSL selling model (PS2) with effective opening, probing, listening, and closing skills on customer calls.Actively work with patient support groups where appropriate, following CSL Behring SOP’s.Stay abreast of pertinent marketplace issues and opportunities and effectively communicates them to manager.Represent CSL Behring at local customer meetings as appropriate to increase exposure of CSL Behring products and services.Regular travel required which may include weekends for select customer or corporate meeting and events. Qualifications: • Bachelor degree in a scientific or business field • Minimum of five years’ pharmaceutical sales or required relevant experience • Demonstrated success with field sales and market share growth • Knowledge of the pharmaceutical market and regulations Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. The expected base salary range for this position at hiring is $110K - $120K Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role will also include sales incentive compensation and may include equity. Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Location: Germany, Spain, UK, or Italy Reporting into the Head of European Medical Affairs, you are responsible for leading medical affairs activities in the assigned therapeutic areas, including the launch of gene therapy product etranacogene dezaparvovec, and lifecycle management of our portfolio, mostly in rare diseases area, by planning, supporting and driving key medical affairs programmes and activities. Within the strategic framework of the assigned therapeutic areas of the CSL Behring portfolio and products you will provide medical leadership, represent CSL Behring with medical experts and lead the development and implementation of effective regional medical initiatives, in collaboration with internal and external stakeholders. You will thus ensure that CSL Behring is positioned as a scientific leader in the therapeutic areas we work in. The role will take over responsibility of the assigned therapeutic areas and will provide support to the other therapeutic areas on a needs basis. You communicate to the countries, within the region and to global functions. You will represent CSL Behring as a speaker and expert at congresses, round tables and other external venues. The job requires interaction at a high-level provided throughout Europe. Despite having no direct people management authority, you will need to provide leadership to matrix teams. A good command of English, coupled with other European language skills. Location is flexible but you are linked to one of the EU offices of CSL Behring. The job involves frequent travel. Main Responsibilities and Accountabilities: You will be responsible for leading the medical affairs strategy for assigned portfolio with overall therapeutic area objectives You will lead the development and implementation of regional medical initiatives (such as medical education), in line with the global strategy and EU affiliate needs You represent Medical Affairs Europe on global teams relevant to the assigned therapeutic areas/franchises (e.g. publication planning meetings, etc.), ensuring needs of the region are appropriately represented through due regional consultation and clear communication on outcomes. You will lead real-world data generation, investigator-initiated studies and research collaborations across EU, partnering with affiliate and global medical colleagues to ensure management of the process for the relevant therapeutic area. You establish and regularly maintains strong peer level professional contacts with medical stakeholders and patient advocacy groups in the region. You will implement strategies for scientific interactions with the medical community including key opinion leaders and patient advocacy groups You evaluate trends and therapeutic opportunities in cooperation with research and regional commercial organizations You ensure high level of medical knowledge across Europe, through identifying and subsequently organizing appropriate training within the region. You will be medical partner to marketing, commercial and research project teams, contributing to promotional and educational materials for relevant therapeutic areas You provide expert input to and lead preparation of European level communications and materials e.g. value dossiers, scientific publications, Q&A documents, and other relevant communications for the relevant therapeutic areas. You support the work stream for the development and implementation of global medical stakeholder plans with a clear focus on region Europe. You provide input into process improvement initiatives. You ensure that all EU Medical Affairs activities within the assigned therapeutic area fully comply with all applicable legal and self-regulatory requirements (e.g. EFPIA code).  Education Degree in Medicine (MD, MBChB or equivalent) Experience 5+ years' pharmaceutical/ biotherapeutics industry experience, or clinical medicine experience in a relevant therapeutic area Prior experience working in a matrix organization desirable Our BenefitsWe encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL. About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring. We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

We are currently recruiting for a Key Account Manager dedicated to Brussels, Namur and Hainaut. The role includes the responsibility for the whole product portfolio. This is a truly unique opportunity to play a key role in the expansion and transformation of CSL Vifor. As a Key Account Manager you will make use and leverage your robust scientific acumen to provide an exceptional and seamless customer experience, conveying information on Vifor's products and relevant disease areas to meet our customer's needs and preferences. * Drives sales performance of products in hospitals in region to planned targets. * Organize expert virtual/live sessions. * DMU management: define new stakeholders and build relationships. * Creates input for national plans with head sales, marketing and medical department. * Identify and develops regional KOL plans in close cooperation with Medical * Develops strong relationships with customers. * Builds and constantly develops knowledge and expertise in key therapeutic areas. * Orchestrates 3M+(s) activities which create a partnership between the customer and CSL Vifor. * Execution of multichannel dialogues with customers. * CRM is used to put in daily calls, as well as TAP creation (SWOT analyses, goals and tactics). The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent. Minimum Requirements * Solid understanding of the complexity and dynamics of the Belgian/Luxembourgian healthcare market, hospital knowledge, RIZIV/INAMI. * Minimum 2 years of experience in the pharmaceutical industry and more specific in hospital markets. * Business/Commercial orientation/acumen with a documented sales track record. * Proven relationship building skills with customers and KOL’s. * Project Managements: ability to initiate, plan, execute and perform/monitor projects. * Fluent in French & Dutch * Good (medical) knowledge of English language (verbal, written). * Digitally excellent versed. * Good knowledge of Microsoft Office software. Preferred Requirements * Sales experience in assigned therapeutic areas (e.g. nephrology, cardiology, patient blood management, anesthesiology, woman's health..) * Ability to implement individual tailored digital customer journeys. * A role where solid understanding of local healthcare market has driven success About CSL ViforCSL Vifor aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. For more information, please visit viforpharma.com We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Vifor!