QA Associate Release CAR-T Europe

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