Skip to main content


QA Associate Release CAR-T Europe

  • Job Title QA Associate Release CAR-T Europe
  • Function Quality
  • Sub Function Quality Assurance
  • Location Ghent, East Flanders, Belgium
  • Date Posted
  • Requisition Number 2306107480W
Apply Now


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


- 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.

Your next move could mean our next breakthrough.

We invite you to join our Global Talent Hub, where we keep in touch with people around the world who share our passions for bold innovations and are inspired by our mission of changing the trajectory of human health.

Join now