Johnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering for the CAR-T hub in Europe. The position will be based in Beerse or Ghent 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, J&J has build two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J&J Beerse site.
In this role, you are reporting directly to the CAR-T Site Quality Head. As member of the site’s Quality Leadership Team, you work closely with your peers from Quality Assurances Operations and Quality Control.
The Senior Manager Quality System & Engineering, CAR-T Europe is accountable for the quality engineering and quality system oversight.
You lead the team of quality system associates, who are responsible for the set up the CAR-T quality management system in alignment with all applicable regulations and Corporate J&J standards.
You lead the team of quality engineering associates who are responsible to maintain and ensure successful qualification of facility & utilities and production equipment of the manufacturing units.
- Set up the CAR-T quality management system in alignment with all applicable regulations and Corporate J&J standards.
- Set up maintain key performance quality indicators. Summarizes and present results to senior management.
- Support quality review meetings governing the quality & compliance as well as the operational business performance. Identify trends and define actions ensuring continuous improvement.
- Act as QA point of contact for the IT, Qualification/Maintenance and Engineering departments during the entire life cycle of computerized systems, facilities & utilities, production equipment and laboratory instruments.
- Ensure validation/qualification related GMP documents such as user requirements, risk assessments, validation plans, protocols and reports as well as investigations, CAPAs, change controls are timely and properly handled (by ensuring the right level of quality and technical expertise) and approved in line with regulatory compliance requirements. Ensure that deviations with potential impact on patient safety and/or product supply are properly escalated.
- Develop and foster an environment of innovative thinking through benchmarking, training and participating in industry fora. Drive the development and implementation of innovative initiatives that deliver sustainable improvement in organizational, quality/compliance and operational performance.
- Establish and maintain effective working relationships with business and quality functions of J&J and our collaboration partner Legend Biotech to ensure compliance with all quality system requirements.
- Provides oversight and maintenance of applicable Quality Agreements.
- Support together with Site QA Head, regulatory health authority inspections.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- You have a master scientific degree or equivalent.
- You have 10 years’ experience in the pharmaceutical industry.
- You have in-depth knowledge in ATMP and GMP (local & international).
- You have Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
- You have experience with qualification of facilities & utilities, production equipment and laboratory instruments.
- You have experience with of leading a team of experts and enjoys supporting, coaching and developing team members.
- You are a proven leader who enables creative thinking and drives implementation of concepts into practical business solutions within a GMP framework.
- The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
- Good written and verbal communication skills are required.