Senior QA/qp Manager Car T Emea

il y a 1 semaine

Gent, Flandre, Belgique Johnson & Johnson Temps plein

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Senior QA/QP Manager for the CAR-T hub in Europe.

The position will be mainly based in 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, 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 QA/QP Manager is part of the Quality Leadership Team.

He/She will lead the QA/QP team that is responsible of both investigational medicinal and commercial CAR-T products out of the Janssen/Legend Biotech facilities in Ghent.

The Senior QA/QP Manager will provide QA input and decisions based upon a combination of cGMP knowledge (expertise in advanced therapy medicinal Products (ATMP) regulations) and expertise of cell and gene therapy processes and/or process technologies to establish the appropriate holistic Process Control Strategy.


Major Responsibilities:

  • Lead the QA/QP team that is responsible of both investigational medicinal and commercial CAR-T products out of the Janssen/Legend Biotech
facilities in Ghent- Act as an expert resource in assessing and maintaining quality and compliance levels

  • Continuously challenge the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
  • Provide QA expertise in the Technical Operations discussions based upon a combination of intensive GMP knowledge of ATMP's, knowledge in aseptic techniques and extensive process knowledge of cell and gene therapy products
  • Establish and maintain effective working relationships with the different business partner and Legend Biotech to ensure alignment of objectives and deliverables
  • Ensure quality oversight of the operational activities by documented QA approval of GMP documentation and support in the different quality review meetings
  • Ensure and manage the implementation and execution of the different quality system processes
  • Support the operational and QA departments by providing coaching and/or training
  • Ensure that deviations/complaints are timely and properly investigated. Deviations/complaints with potential impact on patients and/or product supply are properly escalated
  • Ensure that adequate CAPA's are defined for investigations with potential quality impact
  • Act as key spokesperson for Health Authorities

Qualifications:

Experience and Skills:

Education/Experience:
Master Degree in Pharmaceutical Science, Bio

  • Engineering, or equivalent technical discipline is required. A minimum of 810 years within the biotechnological pharmaceutical industry with relevant experience related to manufacturing of Cell and Gene Products is required. A Certified Industrial Pharmacist is an advantage.

Key Capabilities, Knowledge, and Skills:

  • Strong People leader skills
  • Strong analytical thinking and decisionmaking skills.
  • Indepth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
  • Uptodate knowledge and indepth understanding of relevant pharmaceutical legislation related to clinical trials and cGMP regulations related to manufacturing of cell therapy products as well as knowledge of Good Tissue Practices.
  • Excellent verbal and written communication skills to negotiate and communicate with external and internal customer and partners.
  • Experience working with Quality systems is required.
  • Experience with aseptic processing and technics is required.
  • 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.

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