QA CAR-T Qualification Lead EMEA

Johnson & Johnson Innovative Medicine is recruiting a CAR-T QA C&Q Lead Engineer 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, J&J IM 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 CAR-T QA C&Q Lead Engineer is part of the CAR-T QA Qualification Team in Ghent.

He/She will be responsible for review and approval of qualification and requalification activities, related to Facilities and Utilities (F&U) and Process Equipment at the Janssen/Legend Biotech facilities in Ghent.

Job Responsibilities:

The preferred candidate :


* Responsible for managing a team of CAR-T QA Qualification Engineers and providing QA oversight for qualification activities.


* Will work closely together with the MAM (make asset management) and E&PS department and guard the qualification status of critical production assets by ensuring that all system critical aspects related to facilities & utilities, product and process requirements are identified; qualified and controlled by a mitigation plan and ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented


* Will work closely together with the manufacturing department to approve new change controls and to ensure that deviations with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented


* Will build a strong connect with different quality organizations (e.g.

external quality)


* Will manage the compliance status of critical production (make) assets by means of review and approval of procedures e.g.

calibration rationales, calibration master forms and completed calibration records, master data set-up, maintenance plans and follow up daily operations activities by review and approval of data integrity deliverables such as system audit trail and user access reviews


* Participates in the preparation for regulatory and customer inspections and act as a spokesperson for QA qualification


* Approves qualification documents (change controls, master documents, protocols, reports, rationales, SOP's, URS, IA, QSR, etc.) including discrepancies/events/non-conforming situations and related corrective actions (correction, CPA) occurring during execution of qualification activities.


* Participates in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a ...