QA/qp Operation Director Car T
Il y a 7 mois
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.- 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 starting up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.- The QA/QP Director 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 QA/QP Director 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
- Provide quality oversight of the QA cryopreservation Lab in JSC Beerse
- 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**:
- Education/Experience: Master Degree in Pharmaceutical Science, Bio
- Engineering, or equivalent technical discipline is required. A minimum of 8-10 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 decision-making skills.
- In-depth understanding of pharmaceutical product development, qualification, packaging, validation, testing, release and distribution processes.
- Up-to-date knowledge and in-depth 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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