QA Associate CAR-T EMEA

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:

ohnson & Johnson (J&J) is recruiting a QA Associate 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 build two CAR-T manufacturing centers in the Ghent area (Belgium).   The QC laboratories are operating from the existing J&J Beerse site.  CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities. 

In this role, you are reporting in the J&J QA CAR-T organization and work closely with your peers from Material Science and Technology, Operations and Quality Control.

The QA Associate, CAR-T Europe is responsible that product and process related investigations, complaints, batch review and release activities are properly handled on time and in line with all ATMP/GMP requirements.

Major Responsibilities:

Investigation Support: Provide technical, quality, and compliance expertise to support in-depth investigations related to deviations, complaints, and other quality issues to ensure timely resolution.

Deviations and Complaints Management: Ensure that deviations and complaints are promptly and thoroughly investigated, with particular attention to those that may affect patient safety or product supply.

Escalate issues that could have significant impacts on quality.

CAPA Management: Ensure that appropriate corrective and preventive actions (CAPAs) are identified and implemented in response to investigations, especially those with potential impacts on product quality and patient safety.

Inspection and Audit Support: Assist in the preparation, execution, and follow-up of internal and external inspections and audits to ensure compliance with Good Manufacturing Practices (GMP) and other regulatory requirements.

Quality Oversight Participation: Contribute to the quality oversight programs by providing documented QA approval for GMP documentation and actively participating in quality review meetings to support operational activities.

Collaboration ...