Sr Manager QC, CAR-T Europe

仕事内容

Senior Manager Quality Control, CAR-T Europe
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior Manager Quality Control for the CAR-T manufacturing hub in Europe. The position will be based in Beerse Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
To support the CAR-T program in EMEA, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The Senior Manager Quality Control, CAR-T Europe is accountable for the implementation and execution of the Quality Control programs for CAR-T and manages a team of people leaders and technical professionals. The Senior Manager Quality Control is æresponsible for the timely release testing of CAR-T finished products manufactured in the Ghent manufacturing hub.
Quality Leadership:
- Lead the Quality Control team by supporting, coaching and developing team members in reaching quality, business and personal objectives
- Establish and maintain effective working relationships with business and quality functions of Janssen and our collaboration partner Legend Biotech to ensure alignment of objectives and deliverables
- Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance

Operational Quality performance:
- Manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.
- Responsible for test method verification, qualification and/or transfer activities in the Beerse QC laboratories
- Responsible for raw material, environmental/utility, product release, and stability testing.
- Provides expertise in troubleshooting complex laboratory issues and demonstrates strong technical and analytical skills in support of ongoing laboratory investigations.
- Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeias while remaining current in on-the-job training requirements.
- Collaborates with Quality Assurance, Analytical Development, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
- Contributes to global strategies related to the QC laboratories which align with compliance and business objects as well as the overall Supply Chain vision.
- Manages departmental budget and resources; prepares staffing plans. Makes adjustments to roles and responsibilities of department to meet business needs.
- Organizes and consistently performs tasks in compliance with all internal and external relevant safety and environmental requirements
- Ensures cGMP compliant operation of the QC labs.