CSL

The Opportunity: Reporting to the General Manager of CSL Vifor Brazil, as the Brazil Regulatory Affairs Head, Senior Manager, you will represent Vifor Global Regulatory in Brazil by providing support to the global GRA project team and local affiliate with the preparation of the regulatory submissions, and supporting Global Regulatory Affairs in the development and monitoring of long- and short-term product regulatory planning related to new registration and life cycle management in Brazil. You will also develop and evaluate registrations strategies to ensure effective achievement of regulatory/business objectives, approvals, and optimal labels. You will monitor national registration requirements through reviews of websites, publications, seminars, and similar sources, and communicate requirements to GRA and local staff, as well as proactively address industry trends and opportunities, and key regulatory trends related to registration requirements supporting new product approval. This is a hybrid role, which requires some onsite work. #LIHybrid The Role:Support the compilation, submission and maintenance of NDA, in alignment with RA International strategy.Review and approve product information, customer medicine information, labels and other documentation as required for local regulatory compliance.Act as primary Vifor RA representative in front of the ANVISA (QP or Deputy QP in the future.Interact with local RA partners and / or local health authorities to drive regulatory activities approval.Develop advocacy, support Authority management with stakeholder mapping and proactively build and strengthen external stakeholder contacts (external experts, industry organizations, etc.) in Brazil.Contribute to development of Vifor local Regulatory procedures and policies, including adapting global templates to local affiliate needs.Maintain GRA archiving and tracking systems with local documents to ensure easy and quick access to all documents and transparency on activity status.Maintain up-to-date regulatory intelligence on the local legislation and regulatory requirements and communicate requirements to GRA and local staff.Inform relevant management functions of industry trends and opportunities that impact Vifor portfolio and business.Coordinate and support the transition of the Mas transfer to a new partner.Coordinate and support post MA Transfer activities: due diligences, GAP analysis. life cycle activities.Work and support the implementation of Vifor Brazil as import and distribution company of drug products and pharmaceutical ingredients in Brazil. Your Skills and Experience:Registered Pharmacist is preferred.University degree, preferably in pharmaceutical or health related field.Minimum 10 years in equivalent position in multinational companies in regulatory affairs in in the pharmaceutical industry (prescription drugs).Professional in Portuguese and English (oral and in writing) required, with Spanish knowledge preferred.Proven, first-hand experience of working in a fast-paced team environment.Proven, first-hand experience of NDA submission in Brazil.Experience in working in a matrix organization and multidisciplinary team within the pharmaceutical industry.Familiarity with the global regulatory environment and GCP regulations.Good computer skills, including proficiency with MS Office (including Word and PowerPoint.Able to influence regulatory policy shaping in Brazil in different spheres such as Federal Government, Estate and Municipalities.High familiarity with CEMED processes and the ability to bridge price, registration, and patient needs.High credibility with Brazilian authorities and Pharma associations.Have submitted minimum 10 products in the Brazilian market, with vast experience in launches.Very good understanding on manufacturing, QQ and QA.Experience in pharmacovigilance regulations and clinical development preferred.Experience in Quality Assurance and the stablish of a company as importer and distributor at Anvisa Level preferred. 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!

We are looking for a Senior Manager "Strategic Planning" for our global Analytics team. You will report into the Head Strategy Office within the Research and Development Organization. We are responsible for all Analytics within the plasma product development organization. The responsibilities include defining analytical strategies, method development, characterizing our products, and improving our analytical platforms. As a senior manager "Strategic planning", you coordinate with the proper functions to establish analytical innovation and globalization strategies. You are also coordinating analytical strategic initiatives. For example, you plan digitalization, PAT initiatives, and other programs with global teams. To allow Agile resource allocation and to establish the lab and workforce of the future, you are also responsible for planning and tracking budget and workforce metrics. Responsibilities: · Partners to establish analytical innovation and globalization strategies and plans and coordinates corresponding strategic projects. · Is responsible for integrated planning, including project/initiative timelines, budget, and workforce metrics. Provide high-level scientific expertise and guidance in specialist technical areas of research and product development related activities. · Implements technical capabilities with and provides relevant technical guidance to other team members to achieve specified research project objectives within defined time parameters. · Contributes to the planning, performance, evaluation and reporting of scientific experiments at the highest levels of scientific integrity · Contributes to training of staff in relevant research and development technology platform Qualifications: · Postgraduate degree (preferably MSc or) or experience in relevant discipline. · 5+ years’ experience in pharmaceutical/biotech analytical development. · 3 -5 years' experience in scientific achievement in relevant Life Sciences discipline. · Experience working in, multicultural and international teams. · Excellent communication skills (English language). Different qualifications or responsibilities may apply based on local legal or educational requirements. Refer to local job documentation where applicable. This is a remote position #LI-Remote Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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!

For our GCSP department, we are looking for a Senior Medical Evaluation Lead (m/f/x) – R-217923 (Fulltime / permanent) The Opportunity As a Senior medical Evaluator, within CSL Behring’s GCSP department, you will be responsible for guidance and clinical expertise on all aspects of individual case assessments throughout the entire lifecycle of a product, with special emphasis on ongoing evaluation of safety information during early clinical development and prioritizing cases in late-stage development and post-marketing. The Role (List responsibilities in order of importance)(This list does not need to be exhaustive, focus on the main or important responsibilities)Your main responsibility in this role will be the evaluation of individual case safety reports, using medical judgment for the analysis and interpretation of complex clinical safety data As an expert for medical evaluation, you will identify potential challenges, risks, and roadblocks associated with individual case assessments.You will provide Key information to prevent harm from adverse reactions in humans arising from the use of authorized medicinal products within or outside the terms of the market authorizationAnother focus will be the interfaces with key high-level internal and external stakeholders, and contribution to and approval of regulatory reports/submissions/queriesYou will support the Global Safety Lead and the Safety Scientist in providing strategic input into clinical development and regulatory activities Your Skills and Experience: Advance Science Degree (MD or international equivalent preferred) More than 5 years pharmaceutical / CRO industry experience, of which at least 2 should be in a medical evaluation role, with broad overview of all aspects of a PV system and specific experience in regulatory requirements.At least 2 years of clinical practice experience We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. What we offer Innovative work-environment at our R&D campusCompany BikeChildcareGymWellnessdays Our Benefits We 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 CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat hemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. We want CSL to reflect the world around us As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL. Do work that matters at CSL! Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Regulatory Manager, Advertising and Promotion? This position is located in our King of Prussia PA. It is a Hybrid role. You will report to the Team Lead, Advertising & Promotion, GRA, Region North America Responsibilities: You will have principal accountability: ensure compliance with health authority drug promotion and promotional labeling regulations for assigned licensed products. Review or reject promotional programming based on US Code of Federal Regulations, FDA's implementing regulations and guidelines established by Health Canada. Follow related SOPs and work instructions for established internal processes. Review advertising and promotional labeling; comment, improve, approve, or reject material based on established company practice, CSL Policy, US Law and the FDA's implementing regulations Collaborate with Commercial Operations Marketing, Legal & Medical personnel to minimize/mitigate health authority enforcement risk while also advancing CSL's commercial success Provide regulatory guidance to the marketing team during the development and approval of product promotional programming/materials for assigned Therapeutic Areas Prepare and submit advertising and promotional labeling materials to the FDA under 21 CFR 314.81(b)(3)(i) As assigned, review and advise product development teams' communication strategies regarding investigational products Maintain technical biopharmaceutical/medical knowledge for assigned therapeutic areas Qualifications: Bachelor's degree in a Life Science or Business Advanced degree in a Life Science 1+ years regulatory experience in promotional labeling review and OPDP/CDER/FDA submission experience BENEFITS Medical, Dental Vision 401K Paid time Off #LI-Hybrid 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 CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. 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!

Currently, CSL Vifor has an excellent opportunity for a Medical Science Liaison in Dialysis position to focus on Riyadh and Jeddah areas. Reporting to the Medical Director MENA, the Medical Science Liaison will be responsible for CSL Vifor therapy areas of nephrology and rare diseases therapy areas. Key responsibilities: Develop and maintain scientific and medical expertise (TAs and products) Identify, develop, and maintain relationships with KOLs, HCPs and professional organizations KOL engagement, key account medical support, training, and other appropriate activities Facilitate scientific engagement, scientific exchange and respond to medical requests for medical information Provide Disease State Education and clinical presentations Update medical team and other internal stakeholders on medical community interactions Provide medical support for patient and formulary access products following global and local policies and procedures Support the development, implementation, and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs) Serve as a medical expert for internal medical and sales training Support company sponsored clinical research and IIS (Investigator Initiated Studies) process Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations, or symposia Ensure compliance with applicable local and global laws, regulations, guidelines and company policies and procedures Develop personal and professional capabilities to improve skills and medical competencies The following is the requested profile for a Medical Science Liaison: Registered Pharmacist or a Physician At least 3 years of experience in the pharmaceutical industry and 2 years of experience as an MSL Experience in nephrology therapy/rare diseases area is preferred Ability to travel 60% of the time Fluent in Arabic and English Strong presentation and KOL management skills Demonstrable ability to build external and internal relationships through strong communication, (verbal and written) and good, collaborative networking skills 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!

The Core Analytical Testing (CAT) Team in the Plasma Product Development Department, is currently looking for a Scientist with a solid understanding of biological and chemistry analytical method principles and with relevant experience in analytical method transfer and data analysis. This is a great opportunity to work in a collaborative, agile and flexible team. Scientific enthusiasm, creativity, hands-on experience on analytical (bio-)chemistry method and commitment will be essential for the successful achievement of team and organizational goals and timelines. Key Responsibilities and Activities Act as Subject Matter Expert (SME) for analytical topics and provide scientific input. Provision of scientific and analytical expertise for root-cause analysis related to investigation/deviations studies, process development activities, and other studies as requestedImplement and set up automated workflows, Instruments and tools.Support digitalisation initiatives and routinely use Lab Management Sytems (e.g., ELN, LIMS)Design and conduct appropriate studies to answer stakeholders’ questions. Perform data analysis, present the results, and summarize them into reports at the highest levels of scientific integrityEvaluate, optimize and implement state of the art and fit-for-purpose analytical technology to enhance sample testing efficiencyAct as SME for analytical technical transfer – internally and externally – including designing the comparability study, analyse data, present the results to the stakeholders and write reportsProfessional, flexible collaboration in cross-departmental agile project teams, locally and globallyProvide technical expertise and guidance to laboratory technician to achieve specified project objectivesAuthor and reviewer of technical documents, including SOPs, protocols and reports for internal and external partnersEnsure full compliance with the current global and local guidance and applicable GxPs regulationsProvide knowledge about LEAN to support laboratory improvement by applying a data driven approaches Educational background and past experiences BSc or MSc degree in Biochemistry, Chemistry, Biology, Analytical Chemistry with at least 2 years of experience in a Chemistry or Biologic Lab or Laboratory Technician education with at least 10 years of lab experienceSignificant knowledge and hand-on experience on analytical methods such as HPLC, GC, ELISA, PAGE, particle size analysis, nephelometry and chromogenic assay for protein analysis Solid knowledge and understanding on how to work with different LEAN tools to drive small and bigger improvement in the analytical labHand-on experience with method development & optimization activities, method transfer activities (internal or external to CRO) with strong ability to capture, analyse and record scientific data accurately and reliablyProven track record in developing or optimizing robust assays.Strong organisational skills to drive projects such as analytical method transfer, investigations and other studies internally and externally Proactive, detail oriented, keen to learn, positive attitude and co-operative person with ability to multi-task and proficient at working both independently and in a small team environmentExcellent data analysis, writing and presentation skillsStatistical data analysis using corresponding software, e.g. GraphPad or JMPSolid understanding of electronic and computerized equipment in laboratories such as sample management LIMS/StarLIMS, electronic lab notebook (ELN) and document management systems (docNET)Fluent in English verbal and written communication skills with ability to work independently and in a team environment.Proficient in German is a strong plus 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!

For our Clinical Development department in Marburg, we are looking for a Global Medical Coding Lead (G/US/UK) (m/f/x) R-219353(Fulltime / permanent/ non-tariff) The Opportunity As a Global Medical Coding Lead, you will play a pivotal role in ensuring high medical coding quality and consistency across projects. The role provides coding expertise within Clinical Development with responsibility for coding in MedDRA and WHODrug and oversees medical coding activities for adverse events, concomitant therapies and concomitant diagnosis while ensuring the adherence to company and/or product specific coding guidelines. You will lead the central coding thesaurus management as well as the management of thesaurus updates including synonym tables, standardized MedDRA Queries (SMQs) and company specific groupings The Role You will provide coding expertise for the project and trial teams with responsibility for coding in MedDRA and WHODrug of all adverse events, concomitant therapies, and concomitant diagnosis in all clinical trialsOne of your main responsibilities will be to lead the development and maintenance of global standards for coding processes in clinical trials as well as the development of a central coding concept covering both clinical trials coding and coding of spontaneous reportsAnother focus will be for you to oversee medical coding activities and the adherence to company and/or product specific coding guidelines. Part of this will be to ensure coding consistency within and across projects and to develop a standardized coding reporting process You will collaborate with Global Clinical Safety & Pharmacovigilance with regards to central coding thesaurus management for both thesauruses: MedDRA and WHODrugAs an expert in the field, you will manage and supervise the outsourcing of medical coding performed by External Service Providers (ESPs), including training, review of deliverables and relationship managementYou will lead the thesaurus management as well as management of thesaurus updates including synonym tables, Standardised MedDRA Queries (SMQs) and company specific groupings and ensure compliance with national and international regulatory requirements (ICH-GCP) and laws as well as company SOPs and guidelines. Your Skills and Experience: Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experienceOther degrees and certifications considered if commensurate with related medical coding experienceAt least 7 years coding experience either in clinical data management or in pharmacovigilance department, within the ESP/pharmaceutical environmentProficient knowledge of at least one coding tool (e.g., Medidata Coder, Veeva Coder, Oracle), thesauruses: MedDRA and WHODrug, as well as of international regulations of ICH, EMEA and FDAProven track record in leading teams or projects and in the supervision of ESPs What we offer Innovative work-environment at our R&D campusCompany BikeChildcareGymWellnessdays We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. Marburg, 08.11.2023 CSL Behring Innovation GmbH Human Resources Requisition: R-219353 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!

This role is a leadership position in the Primary Packaging and Medical Devices (PPMD) department within CSL R&D. Qualifications Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to Device and/or Combination products including 21CFR Part 4, Part 820, ISO 13485, ISO14971 and device ISO/AAMI standards.Broad medical device /combination device technical knowledge of current industry trendsProven ability to develop strategies and lead improvement projects.Excellent communication skills and a track record working in a matrix environment; Influencing/building/promoting a culture of continuous improvement.Strong leadership through a partnership and engagement approach with manufacturing for advancing quality outcomes and operational excellence.PhD or other advanced degree in areas such as Engineering, Natural Sciences, or other relevant area.At least 10 years of related experience in medical device or combination product development/support in the pharmaceutical industry.Responsibilities Set and drive best practices within PPMD for combination product development.Create and maintain standard operating procedures, work instructions, and templates for PPMD to use in the development of combination products.Ensure compliance with current and emerging global device/ combination products legislation. Will require interaction with critical partner groups such as Combination Product Quality, Regulatory Affairs, and multidisciplinary, multi-site groups, which may include technology transfer teams, external vendors, and other strategic suppliers. Collaborate with key stakeholders in CSL to evaluate new device technologies to meet pipeline needs. Establish productive collaborations between R&D, Operations, and the third-party suppliers to progress development projects.Author and or review technical documents for regulatory submissions and responses to regulatory agency questions on combination products. Lead combination product/ device engineers and scientists to effectively handle commercial biological/drug-device combination product development. Drive the development of combination products, accessories, and ancillaries as required by the business.Identify and develop talent to meet PPMD business requirements. Plus develop robust succession plans that provide career opportunities for individuals while and supporting business resiliency. 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!

Für die Gruppe Pilot Plant unserer Abteilung Plasma Product Development in Marburg suchen wir aktuell eine Supportkraft PRD (m/w/d) - R-218648(Vollzeit / unbefristet / Tarif) Sie unterstützen den Produktionsbetrieb PPD Pilot Plant, welcher Material für wichtige Studien im Rahmen der Entwicklungsarbeiten für neue und optimierte Produktionsprozesse herstellt. Sie stellen sicher, dass Materialien für und von Produktionsläufen gemäß Vorgaben vor- und nachbereitet werden, und arbeiten mit einem kleinen Team zusammen, um sicherzustellen dass alle betrieblichen Abläufe mit den benötigten Materialien versorgt sind. Die Aufgabe: Sie holen und verteilen Spülgut im Bereich, führen Reinigungen und Sterilisationen durch und dokumentieren diese Arbeiten nach Vorgabe. Sie unterstützen die Vorbereitung Auf-/Abbau von Anlagen, z.B. Zusammenbau von einfachen Prozessaufbauten nach Anweisung, Zusammenbau von EdelstahlkesselnSie sorgen für die Sammlung und Verteilung der Laborkleidung vor/nach Reinigung, die Ausstattung der Schleusen mit Laborkleidung sowie Warenannahme und Lagerung im Bereich, führen Botengänge des Bereichs durch (z.B. Probenverteilung oder Materialtransport am Standort), und sind beteiligt an Reinigungs- und Hygienemaßnahmen im eigenen Zuständigkeitsbereich.Sie prüfen und pflegen GxP relevante Dokumente wie Überprüfung von Prozessdaten (z.B. Sterilisationsläufe), Temperaturkontrollen, ChartrecorderaufzeichnungenWeiterhin gehören zu Ihren Aufgaben das Gerätemanagement zu unterstützen und Arbeiten durch externes Servicepersonal zu begleiten Deine Fähigkeiten und Erfahrungen: i.d.R i.d.R. abgeschlossene 2-jährige Ausbildung, z.B. zur Produktionsfachkraft Chemie Von Vorteil: praktische Erfahrung im GMP reguliertem Produktionsumfeld (Reinraumerfahrung, 5S+)Erfahrung mit Inbetriebnahmen und Qualifizierungen von Prozessequipment und der Bedienung von Pharmaspülmaschinen und - Autoklaven Unsere Vergünstigungen und Zusatzleistungen JobradFitnessstudioKantineWellnesstage Bitte bewerben Sie sich online mit Ihren vollständigen Bewerbungsunterlagen (Lebenslauf und Zeugnisse) sowie Ihren Gehaltsvorstellungen. Wir freuen uns auf Ihre Bewerbung! 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!

Für die Gruppe Pilot Plant unserer Abteilung Plasma Product Development in Marburg suchen wir aktuell eine/n Senior Engineer - Manufacturing Science & Technology (R&D Pilot Plant) (m/w/d) R-218647(Vollzeit / unbefristet / Tarif) Sie arbeiten im Team PPD Pilot Plant, welches Material für wichtige Studien im Rahmen der Entwicklungsarbeiten für neue und optimierte Produktionsprozesse herstellt. Sie sind verantwortlich für Optimierung von Prozessaufbauten und – Abläufen um sicherzustellen dass diese produktionsnah aufgestellt sind. Hierzu gehören sowohl Identifizierung von geeigneten Systemen als auch die Durchführung von Produktionsprozessen inklusive Optimierung von Aufbauten und Einstellungen. Die Aufgabe: Sie sind verantwortlich für die ständige kritische Analyse von Produktionsprozessen, technischen Anlagen und Prozessabläufen, um Optimierungspotenzial zu erkennen und zu implementieren. Sie unterstützen die Produktion von Pilot Plant Produktherstellung (zur Unterstützung von zB präklinischen, klinischen oder Stabilitäts-Studien)Sie wirken an der Aufarbeitung von Prozessvariationen mit und unterstützen die Arbeit mit Änderungsanträgen. Sie arbeiten an der Erfassung von Prozess-Daten aus diversen Systemen und Datenbanken sowie an der Erstellung von Graphiken zur statistischen Prozesskontrolle. Weiterhin unterstützen Sie Erstellung und Versionierung diverser abteilungsspezifischen Dokumente. Sie unterstützen Tech Transfer Aktivitäten hinsichtlich Skalierung von Prozessen, Process Fit-Analysen, Auswahl und Aufbau von Prozessequipment, Erstellung von Dokumenten. Sie arbeiten eng mit verschiedenen Abteilungen zusammen (Prozessentwicklung, Produktion, Engineering) und fungieren als Schnittstellenfunktion als fachlicher Ansprechpartner für prozess- oder technologiebezogene Fragestellungen Sie leisten Ihren Beitrag zur Etablierung eines modernen Produktionsbetriebs mit innovativen Prozessanlagen und mit einer zentralen innovativen Dateninfrastruktur Ihre Fähigkeiten und Erfahrungen: abgeschlossenes Studium zum Bachelor of Science, z.B. Pharmatechnik, Verfahrenstechnik oder Maschinenbau in der Biotechnologie4 – 5 Jahre BerufserfahrungEnglisch Level 2 Von Vorteil: Erfahrung im GMP reguliertem Produktionsumfeld sowie mit Changes und AbweichungsbearbeitungErfahrung in der Erstellung von regulierten Dokumenten sowie der Inbetriebnahme und Qualifizierungen von Prozessequipment Kenntnisse in der Evaluation von geeignetem Prozessequipment und der Erstellung von Beschaffungsdokumenten sowie NutzeranforderungenErfahrung in der Bedienung verschiedener komplexer Prozessanlagen (z.B. Chromatographie, TFF) sowie der Evaluation von Kompatibilitäten von Material und pharmazeutischen Produkten Unsere Vergünstigungen und Zusatzleistungen JobradFitnessstudioKantineWellnesstage Bitte bewerben Sie sich online mit Ihren vollständigen Bewerbungsunterlagen (Lebenslauf und Zeugnisse) sowie Ihren Gehaltsvorstellungen. Wir freuen uns auf Ihre Bewerbung! Marburg, 10.11.2023 CSL Behring Innovation GmbH Human Resources Stellennummer: R-218647 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!

The OpportunityCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Manager, eClinical Systems? The job can be located at our King of Prussia PA or Marburg Germany location. This is a hybrid position. You will report to the Associate Director, Clinical Risk and Document Management. You will be an important member of the Clinical Risk and Document Management team within Clinical Data, Innovation, and Technology (a department within Clinical Development Operations). You will lead the implementation and conduct of clinical systems scope to ensure compliance with ICH GCP E6 R2 and all applicable global regulations. You will ensure availability of clinical systems (including Risk-based Quality Monitoring (RBQM), Electronic Trial Master File (eTMF), Study Startup, (SSU), and Study Team Portal) with the systems’ Process Owners. You will provide oversight of the applicable systems to ensure SDLC documentation is up to date and creating guidance where needed. You will provide oversight to ensure that all activities are documented in the event of a system inspection. This includes user management reports and improvement risk assessments for system releases. You will work with the Process Owner to develop communications to end-users of releases and perform change management activities following the I&T SOP’s. The RoleSupport the System Owners of the clinical development systems by developing the platform strategy. Support/lead account setups and system releases. Establish and support strategies for streamlined configuration support. Lead systems validation efforts, coordinating user acceptance testing, user requirements and configuration management. Contribute to all aspects of system life cycle, representing the business to ensure that user requirements are translated to sound implementation to meet the long-term needs of the organization Your experienceBachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area 5+ years experience managing SLDC principals within the pharmaceutical or a comparable environment An understanding of the clinical research and drug development lifecycle. Proficient in technologies that support clinical trial execution. BENEFITS Medical, Dental Vision 401K Paid time Off #LI-Hybrid Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Director, Global Clinical Operations? This position is located in our King of Prussia PA, Marburg Germany, Bern Switzerland or any other CSL office. It is a Hybrid role. You will report to the Senior Director of Clinical Operations. THE ROLE Director-level position for an experienced clinical research manager working in a matrix environment. You will have budget responsibility over $35Million/year, accountability for delivery in high-volume (# of studies) therapeutic areas (Transplant and Nephrology or Vaccines) and increased management responsibility - four or more Clinical Program Managers reporting to them with complex and visible clinical programs. Provide clinical operations strategic leadership to, and management of all clinical programs within a designated Therapeutic Area (s) to ensure they are planned following our strategy, appropriate international regulatory standards, and within the agreed timeframe and budget. Promote the Clinical Research Program(s), keeping informed about important developments in the therapeutic area including regulatory strategies and competitor status. Be a primary contact with the CSD Therapeutic Area Head concerning Clinical Operations (including program timelines; budgets; and protocol development). Standing member of all Core Project Teams within designated Therapeutic Areas Primary interface for partners (Regulatory/Commercial Operations/Commercial Development/Project Management) regarding operational delivery of clinical programs within a designated Therapeutic Area Manage main program risks and escalate to senior management Provide operational input to the Clinical Development Plan (including assessing the feasibility) and contribute to the program(s) strategy planning. Improve the implementation of the clinical development plan within CRD to achieve program timelines. Responsible for overall forecasts and management of clinical program(s) budgets and resource allocation in collaboration with the primary budget responsible member of the Clinical Operations team and Head of Clinical Operations. Ensure clinical program is in compliance with ICH GCP, SOPs and regulatory requirements. In collaboration with Clinical Development Personnel and Regional Clinical Operations Personnel, establishes links with investigators and main opinion leaders and appropriate professional bodies in the therapeutic area. Manage a team of Clinical Program Managers and Clinical Study Managers, with responsibility for their coaching QUALIFICATIONS Bachelor's degree, or equivalent, in Science related discipline post graduate qualifications in scientific or business related field preferable. 10+ years experience working in a Clinical Operations environment is required Leadership experience and global Clinical Operations experience is necessary . BENEFITS Medical, Dental Vision 401K Paid time Off #LI-Hybrid Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 Opportunity: We are hiring a Scientist to join our Translational Research team on a 12-month fixed term contract. The Translational Research group is responsible for the evaluation and development of novel protein-based therapeutics, such as recombinant antibodies and other protein mediators that target and modulate the function of specific cell types. You will develop, validate and perform key biological assays (in vitro or ex vivo) and evaluation of the therapeutic candidates in human clinical samples. Reporting to Senior Research Scientist, Translational Research, you will: Responsibilities: Investigate modes of action of multiple antibody and other recombinant protein projectsDevelop and perform in vitro high-throughput functional cellular assays to assess potential therapeutic candidates (e.g. proliferation, survival, invasion, and migration on Incucyte live cell imager)Develop and perform flow cytometry-based assays to evaluate leukocyte activationPrepare and perform protein analysis of cell supernatants, cell and tissue extracts (e.g. ELISA/ Luminex/MSD)Perform basic molecular biology including DNA/RNA purification (from cells/PAXgene tubes and use of QiaSymphony), qPCR, and preparation of samples for NGS.Work with human cells and tissues in vitro (i.e. tissue culture) to evaluate efficacy of therapeutic candidates Your Experience: Tertiary degree with honours in relevant discipline (e.g. Biological Sciences, Immunology or Molecular Biology) with at least 2 years experienceExperience in cell culture and aseptic techniqueExperience in flow cytometryExperience in immunological techniquesExperience with molecular biology and RNA extraction and handlingExperience in writing scientific reports and upkeep of electronic lab notebooksProficiency in the use of Microsoft Office programs (Word, Excel, Powerpoint, Teams, Outlook), statistical analysis (e.g. Prism, JMP, R-Studio/R-related skills) and Flow Cytometry Analysis Programs (e.g. FlowJo)Experience in assay development and validation desirableKnowledge of GLP desirable Apply now to join Australia’s largest bio-pharmaceutical company, committed to protecting public health! Applications Close on 26 November 2023 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 CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. 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!

About CSL Behring CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn. Program Summary The Biostatistics Intern position is open to graduate students in Statistics, Biostatistics or a closely related field. Interns will gain hands-on experience in the pharmaceutical industry while assisting the CSL Behring’s Department of Biostatistics and Medical Writing with important R&D program work. Responsibilities The Biostatistics Intern will be involved in the following activities: Perform statistical research or assist in developing statistical methodology related to drug developmentAssist in data analysis and data explorationImplement new statistical methods related to drug developmentConduct simulations to explore statistical properties of clinical study designs and analysis approachesOther duties as assigned by manager Qualifications Currently enrolled in a graduate program in Statistics, Biostatistics or a closely related field and have completed at least 2 semesters of graduate work towards a Master’s degree or PhD prior to the start of the internship, or have a comparable level of courseworkGood working knowledge of SAS and/or REffective oral and written communication skills in English Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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!

About CSL Behring CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, inherited respiratory disease, and neurological disorders. The company's products are used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic disease of the newborn. Program Summary The Biostatistics Intern position is open to graduate students in Statistics, Biostatistics or a closely related field. Interns will gain hands-on experience in the pharmaceutical industry while assisting the CSL Behring’s Department of Biostatistics and Medical Writing with important R&D program work. Responsibilities The Biostatistics Intern will be involved in the following activities: Perform statistical research or assist in developing statistical methodology related to drug developmentAssist in data analysis and data explorationImplement new statistical methods related to drug developmentConduct simulations to explore statistical properties of clinical study designs and analysis approachesOther duties as assigned by manager Qualifications Currently enrolled in a graduate program in Statistics, Biostatistics or a closely related field and have completed at least 2 semesters of graduate work towards a Master’s degree or PhD prior to the start of the internship, or have a comparable level of courseworkGood working knowledge of SAS and/or REffective oral and written communication skills in English Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 Opportunity: We have a 12 month opportunity available for a Scientist to join our Cell Line Development team. You will assist Senior Scientists within the Molecular Biology Department with specified project goals within defined time parameters. You will work both autonomously and in collaboration with other members of the Molecular Biology Department. Your main tasks may include the development of cell lines expressing candidate therapeutic proteins and general cell culture activities. Reporting to the Senior Scientist - Cell Line Development, you will: Apply scientific and technical capability in respect of mammalian tissue culture and cell line development to meet main project goals.Maintain awareness of new scientific/technical strategies in the area of tissue culture / cell line development.Contribute to the maintenance of research resources on-site.Attend and participate at research group meetings/reviews.Ensure documentation and recording of all laboratory notes and research on projects are up to date, secure and accessible observing Laboratory Notebook guidelines.In collaboration with supervisor, plan and perform experimental work relevant to project specific goals. Your Experience: Tertiary qualification in a relevant scientific discipline, with experience in relevant industry or academic environments.Expertise in mammalian tissue culture and recombinant protein expression2+ years of experience in relevant cell line development technologiesExcellent interpersonal skills Apply now to join Australia’s leading bio-pharmaceutical company, committed to protecting public health! Applications close on 26 November 2023 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 CSLCSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives through innovation. Learn more about CSL. 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!

CMC Lead – Director This senior leadership role will be responsible for project-specific Chemistry, Manufacturing and Control (CMC) teams accountable for CSL plasma product development (PPD) projects. The primary responsibility and accountability of the role is to define and deliver contemporary CMC packages during clinical development, market authorization, and Life Cycle Management (LCM). During early clinical development, the CMC Lead defines the manufacturing plan and ensures clinical supply. To accomplish these objectives, the CMC Lead will provide strategic direction, technical expertise, coordination and oversight of cross-functional, global and local CMC teams including representatives from Process Development Analytical Development, Global Pathogen Safety, Technology Transfer, Quality, Regulatory Affairs, Validation, Manufacturing, and Quality. Role and responsibilities In close collaboration with R&D and operations, defines and ensures execution of the phase appropriate process, analytical, and manufacturing programs.Accountable for development of process control strategy including leading development of product specifications in a cross-functional team.Ensures alignment on and communication of CMC strategies, objectives, and deliverables.Accountable for delivery of the Quality Section during clinical development, market authorization, and LCM changes for the CSL PPD projects including:Maintaining line-of-sight on all aspects of site manufacturing delivery (contracts, production, coordination, validation, regulatory activities).Ensures appropriate and continuous communication with Research, Development, and global CMC groups relating to topics interfacing with CMC and associated activities.Accountable for CMC/QbD related project and product documentation (for example: risk assessments, PFMEAs, monitoring strategies) in accordance with global CMC/QbD policies.Executes globalization/ harmonization initiatives across sites that drive efficiencies, establishes best practices, and return values to CSL Behring. Background education and past experiences Ph.D., Masters, or BSc (or equivalent) in Biochemistry, Biology or related fieldMinimum 10 years of experience in pharmaceutical industry with emphasis on manufacturing operations, process design, and process validation.Demonstrated experience in project management and or leadership by influence preferred.Advanced knowledge of biological manufacturing processes and advanced CMC/QbD requirements for plasma derived or biotechnology therapies is preferred. Technical and regulatory writing experience. Previous experience working across sites and as part of international teams is highly desirable.Track records in leading teams is crucial to perform in this roleFluent in English 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!

For our Global & Regional Regulatory Affairs department in Marburg, we are looking for a GRA Regional Manager Europe (m/f/x) R-220064(Fulltime / permanent/ non-tariff) The Opportunity As GRA Regional Manager Europe you will be responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. The role is also responsible for ensuring effective product maintenance and life cycle management, in line with regulatory requirements and regional business needs. The role also is responsible to contribute the regional regulatory strategy to global development programs. The Role You will serve as Regulatory Regional Manager EU, to support product development and life cycle activities for the CSL Behring product portfolio In this role one of your main responsibilities will be to contribute to the development of global regulatory strategies by providing expert knowledge on most efficient regional regulatory procedures and requirements Another focus will be to strengthen global regulatory teams by providing expertise on regional regulatory guidelines and relevant Health Authority recommendations and assessments You will contribute to the compilation of global and regional briefing packages for Health Authority meetings and high-quality documentation for submissions in the region, including applications for new licenses, variations, license renewals, pediatric plans, orphan drug designations, product identifiers/names, as well as periodic reports according to agreed schedules As an expert in the field you will take responsibility for the management of regulatory procedures like new license applications, renewal applications, variation applications, period reporting submissions, submissions required to fulfill regulatory post approval commitments In addition, you will ensure data entry and timely updates of data entries into regulatory systems You will establish and maintain a working relationship to Health Authorities by efficient communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring and organize and participate in regional Health Authority interactions/meetings Your Skills and Experience: Bachelor degree in Life Science, Medical Science, or Pharmacy, (preferably PhD, MD), Business (MBA) or a degree in Drug Regulatory Affairs is advantageous. 3+ years regulatory experience in the pharmaceutical industry. Biologics Regulatory experience preferredDemonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities. Highly effective communicator with written, verbal and presentation skills in English. What we offer Innovative work-environment at our R&D campusChildcareGymWellnessdays We are looking forward to your application. Please ensure to apply online with your CV and certifications as well as your salary expectation. Marburg, 17.11.2023 CSL Behring Innovation GmbH Human Resources Requisition: R-220064 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 #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!

You will develop and implement programs to improve product and service quality. Reporting in to the Head of Digital Quality, you will develop policies, procedures, and methods to check and improve product, material, components and operational quality. Provide quality oversight during the whole life cycle of computerized systems in scope of GxP regulation and GAMP standards. You will develop and assess quality and system standards to ensure compliance with company standards and GxP regulatory requirements for computerized systems design, implementation and operation including supplier management. Oversee quality performance indexes related to computerized systems implementation and operation. You will shape, direct, and report on supplier/service providers quality activities such as computerized systems, computerized systems validation, to ensure procurements exceed requirements. Design programs to maintain and improve supplier productivity, and computerized systems validation related activities; ensure customer quality-imposed technical and quality requirements are observed by supplier. Responsibilities Lead supplier/service provider qualification activities involving GxP computerized systems in responsibility of Engineering and I&TCreate training material, act as trainer, and implement training sessions related to computerized systems suppliers/service providers qualificationSupport GxP health authority inspections by serving as subject matter expert for computerized systems supplier/service provider related topicsLead QMS improvements in the area of computerized systems supplier/service provider qualification in collaboration with other departments responsible of supplier/service provider qualificationProvide guidance to project teams, internal stakeholders, and other teams related to supplier/service provider qualificationManage staff of external auditors and serve as primary internal interface and contact for all quality related supplier/service provider issues related to computerized systemsCollaborate with colleagues to manage overall supplier quality auditing program; perform quality audits of approved or potential suppliers/service providerIdentify and use best practices to establish appropriate risk management tools and quality KPI's for local operations/quality groupsBe the Subject Matter Expert for Digital Quality QA-Managers for deviations investigation related to computerized systems supplier/service providerManage activities of computerized systems supplier/service provider quality agreements Qualifications Bachelor's degree or equivalent; education preferably concentrated in IT, Quality, Engineering or Science5+ years' quality systems experience in pharmaceutical manufacturing/cGMP regulated environmentKnowledge of current Good Manufacturing Practices (cGMP)Knowledge of FDA and EMA requirements specifically CFR21 part 11 and annex 113+ years auditing experience, internal and external, within the industry The expected base salary range for this position at hiring is $100,000 - $140,000. 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 may also include incentive compensation and equity. #LI-Remote Our BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee. 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 Opportunity 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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 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 managementCollaborate with center management in the development and implementation of continuous improvement plansCollaborate 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 concernsResponsible for coordinating and managing training activities, policies and processes at the center level. You will report to the Assistant Manager Quality The Role Perform final QA review and release for all shipment and associated documents, to ensure shipment meets customer specifications.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.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.Maintain and review Plasma center personnel training documents to ensure documents comply with CSL procedures, SOP’s, CLIA/COLA and other applicable requirements.Maintain the Learning Management System to ensure data integrity, report generation and data analysis to comply with company and regulatory standards.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 usedCollaborates 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.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.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.Promote Safety, Health and Environment Policies & Procedure. Ensure safety training and safety practices are implemented and followed within the center.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.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.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.Follow all Standard Operating Procedures (SOPs), company policies and procedures.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.Maintain confidentiality of all personnel, donor and center information. Understand policies and procedures associated with hyperimmune programs at the center, if applicable.Assist Plasma center staff in completing other special projects or assignments, as requested.Perform other job-related duties, as assigned.dd 4-6 key responsibilities of the job Your skills and experience 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 skillsStrong critical reasoning, decision-making and problem solving skills to analyze situationsOrganizational skills and attention to details to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectivesUnderstand Quality Systems and/or regulated training requirements Working Conditions (physical & mental requirements) Occasionally required to work with the public when they are dissatisfied80% of the time standing and walking and 20% of the time sittingReach, bend, kneel and have high level of manual dexteritySee and speak with customers and observe equipment operationOccasionally be required to lift and carry 25 lbs.Exposure to hot and cold temperatures, sudden temperature changes, working with freezers and various odors 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 an unserem modernen Produktionsstandort in St. Gallen suchen wir eine/n motivierter Monitoring und OE Specialist 100% In Ihrer Position als Monitoring Specialist sind Sie verantwortlich für die Sicherstellung des qualifizierten Zustands der Produktionsräume- und Medienanlagen hinsichtlich aller Monitoring Belange sowie für die Planung, Durchführung und Koordination aller Massnahmen, die sicherstellen, dass die Räume und Medien allen internen und externen Anforderungen entsprechen. Zusätzlich umfasst die Stelle alle am Standort laufen OE-Aktivitäten. Ihre Aufgaben beinhalten im Wesentlichen: Administration und Betreuung des Monitoringsystems CEMSErstellung und Sicherung der relevanten Dokumentation (z.B. Kalibrierprotokolle)Verwaltung der T/rF-Messstellen in Verwaltungsapplikation LIMSGxP gerechte Planung und Durchführung von MappingsInitiierung / Bearbeitung bereichsspezifischer AbweichungenInitiierung / Bearbeitung bereichsspezifischer ÄnderungsanträgeErstellung von Mappingberichten und JahresplanenErstellung und Review von Vorschriften, Berichten und ArbeitsanweisungenStellvertretung im Bereich Raume und MedienAlkohol ManagementErstellung von Quartalsberichten Raume und MedienMitglied im lokalen OE-Ambassador Team Sie bringen die folgenden Qualifikationen und Berufserfahrungen mit: Technische Ausbildung oder Chemielaborant mit Weiterbildung gemäss AnforderungsprofilInteresse und technisches Verständnis für Klimamonitoring und MedienanlagenBerufserfahrung im GMP-, Pharma- oder LebensmittelbereichAffinität für Technik und ITErfahrung mit MesstechnikTeamfähigkeitBelastbarkeitSelbständigkeitKommunikativOE-Erfahrungen resp. fundierte Ausbildung wünschenswert Fühlen Sie sich angesprochen? Dann freuen wir uns auf Ihre Online-Bewerbung. Ihre Bewerbung sollte ein Motivationsschreiben, einen Lebenslauf/CV sowie Arbeitszeugnisse und Kopien von Diplomen in der Originalsprache und/oder relevante Transkripte beinhalten. Bitte fügen Sie Ihre Dateien, inklusive CV, zu einem Dokument zusammen. 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!

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 Montana, Wyoming, Utah, Colorado, North Dakota, South Dakota, Nebraska Or Kansas 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: The expected base pay for this position at hiring is $23.50/hour. Please note this wage reflects what CSL expects to pay for this position at the listed location as of the time of this posting.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!