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.
- 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