Sr Manager QC, CAR-T Europe

Contenido de trabajo

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. Qualifications A minimum of a Bachelor’s Degree in Pharmaceutical, Life Sciences or equivalent technical discipline is required. (Master degree preferred) A minimum of 10 years of experience in Operations Quality and Quality Control is required. People management or leadership experience is required. Experience working with Quality systems is required. Experience with Quality support in clinical manufacture or NPI is preferred. Extensive knowledge of chemical, biochemical and microbiological concepts is required. Experience in clinical quality, method development, cell therapy, or Research & Development is preferred. Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required. Knowledge of cGMP regulations and FDA/EU guidance is required. The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. Comfortable with speaking and interacting with Health Authority inspectors. Good written and verbal communication skills are required. Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function Quality Requisition ID 2105953644W