COMPLETE Head of QC - APAC, CN-42, Wuhan, CSL Behring

Responsible for the management of the Quality Control Laboratories –Chemistry team, Plasma Testing team, Microbiology team and QC support team.

负责管理QC-理化组、血源组、微生物组和支持组。

-Coordinates analytical activities related to Manufacturing, Validation, etc., to ensure timely completion of all testing without impacting the schedule for product release.

协调涉及生产、验证等相关检测活动，确保按照产品放行时限要求按时完成相关检测任务。

-Ensures compliance with GMP regulations for activities that take place within the Quality Control Laboratories

确保QC实验室各项工作符合GMP 相关要求。

-Coordinates Quality Control Laboratories activities with outside organizations.

协调QC 与其他相关方的工作。

-Ensure the development of accurate budgets and forecasts.

Policy and Compliance: ensuring actions comply with:

确保符合以下合规政策

• CSL Behring Ruide Code of Responsible Business Practice.

CSL Behring瑞德员工商业守则

• CSL Behring Ruide Quality Manual (WHM-SMP-00171).

CSL Behring 瑞德质量手册（WHM-SMP-00171）

• GxP requirements (CFDA NMPA, blood products)
• GxP要求（如CFDA NMPA、血液制品等）
• CSL’s Environment, Health, Safety & Sustainability Management System referenced to SOP-GEHSS-006 CSL EHS2Management System and POL-0410 EHS2 Global Policy.
• 的环境、健康、安全和可持续发展管理系统（SOP-GEHSS-006 CSL EHS2管理体系和POL-0410EHS2全球政策）

Management duties 管理责任:

• Operational, i.e. personnel, technical and financial lead of the Quality Control Laboratories:
• QC实验室的运营，比如人员，技术及成本等。

 Live CSL Values and implement CSL Guidelines

• CSL的价值观并贯彻CSL各项指导原则

 Achieve approved divisional targets

• Plan and supervise of optimal use of resources (staff, material, equipment and rooms) to ensure efficiency and achievement of targets
• Development of staff through training, further education and delegation of duties
• Encourage and facilitate team spirit and motivation of staff by means of regular positive and negative feedback
• Evaluation of department’s target achievements and performance evaluation of direct reports regularly
• Generate and actively manage further education planning and position descriptions of direct reports
• Generate and achieve department budget
• Ensure meet data integrity requirements in whole data life cycle. Be responsible for  data integrity in QC.
• Nurture efficient Communication 促进有效沟通:
•  Ensure that staff and colleagues, as well as customers always receive the appropriate and required information
• Regularly inform superior about current business as well as problems within division.

Technical duties 技术责任:

• Professional and timely completion of the microbiological and biological, chemical and biochemical analytics (final products, plasma, intermediates, raw materials, environment, utilities, disinfectants, cleaning processes etc.) and associated support activities such as sample logistics and documentation.
• Consistent, professional and timely capture and editing of OOT/OOS-results and deviations. Finish investigation timely.
• OOT/OOS和偏差，并及时完成相关调查
• Professional and timely generation and editing of the QC owned SOP’s
• QC 的SOP的制定、修订。
• Professional and timely evaluation, development, validation and re-validation of microbiological and biological, chemical and biochemical analytical test procedures
• Professional and timely evaluation, procurement, qualification, re-qualification, maintenance, calibration and monitoring of the divisional equipment
• Establish and maintain contacts with external partners, (contract laboratories, technical high schools and universities, expert groups etc.) together with participation and evaluation of external inter-laboratory tests such as national and international studies
• Collaboration in resolution of technical problems or questions (quality problems, questions from authorities etc.)
• Respect the CSL Guidelines regarding health, safety and environment
• CSL EHS 相关要求
• 技术，经验及相关知识要求：
• Team leadership
• Proven experience in Quality Control processes in a medical or pharmaceutical GMP regulated environment
• GMP环境下质量控制管理经验
• Good technical understanding of QC test methods and analytical equipment.
• QC检验方法及分析仪器
• Languages: English fluent, written and spoken
• 流利的英语读、写、说能力
• Communicates Effectively
• Stakeholder Management
• Costumer focused
• Develops Talents
• Drive for Results
• Manages Ambiguity
• Strong talent for organization and coordination of various tasks or projects
• Good time management skills, with the flexibility to manage changing priorities and multiple tasks.
• Innovation Management

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About CSL Behring

CSL 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.

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