QA Investigations Manager CAR-T

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Gent, East Flanders, Belgium

Job Description:

Johnson & Johnson (J&J) is recruiting a QA Investigations Manager 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, J&J has constructed two CAR-T manufacturing centers in the Ghent area (Belgium).

The QC laboratories will be operated from the existing J&J Beerse site.

CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities. 

The successful candidate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements.

This role involves working closely with cross-functional teams, including Manufacturing Science and Technologies, Operations, Manufacturing and the Vein-to-Vein department.

The QA Investigations Manager, CAR-T will be reporting into the J&J QA CAR-T organization.

The QA Investigations Manager CAR-T is responsible to execute QA investigation documentation reviews, to lead the QA investigation team and to manage the quality assurance activities pertaining to the investigations related to the CAR-T cell therapy manufacturing, ensuring compliance with regulatory standard.

Major Responsibilities:


* Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products.
 


* Investigation and Compliance Expertise: Provide technical, quality, and compliance expertise to support thorough investigations of deviations, complaints, and other quality issues to ensure timely and effective resolution.
 


* Deviation & CAPA Management: Investigate deviations, non-conformances, and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality.
 


* CAPA Implementation: Identify and implement corrective and preventive actions (CAPAs) to address quality issues from investigations, particularly those affecting produ...