QA Associate Release Car-t Europe

il y a 2 semaines

Gent, Belgique Johnson & Johnson Temps plein

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Associate Release for the CAR-T hub in Europe. The position will be 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 QA Associate Release CAR-T Europe is responsible for the release of CAR-T investigational medicinal and commercial CAR-T products manufactured in the Ghent facilities.

**Major Responsibilities**:

- Taking responsibility as Release Responsible of both investigational medicinal and commercial CAR-T products manufactured at the Janssen/Legend Biotech facilities in Ghent.
- Act as an expert resource in assessing and maintaining quality and compliance levels
- Continuously challenging the status quo and lead the development and implementation of breakthrough initiatives that deliver sustainable improvement in organizational and quality performance
- 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
- Review of batch documentation and review analytical results
- Support in-depth investigations by providing technical, quality and compliance expertise
- 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 CAPAs are defined for investigations with potential quality impact
- Support the preparation, execution and follow-up of inspections and audits

**Qualifications**:

- A minimum of a Bachelor Degree in Engineering, (Pharmaceutical) Science or equivalent technical discipline is required.
- At Least 3 years cross functional experience in pharmaceutical industry is required.
- 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.
- Strong analytical thinking and decision-making skills.
- 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 preferred.
- 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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