Qualified Person (QP) – Quality Assurance

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:

About Innovative Medicine  

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements.

Visionaries like you work on teams that save lives by developing the medicines of tomorrow. 

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. 

Learn more at https://www.jnj.com/innovative-medicine 

We are looking for the best talent for a Qualified Person – Quality Assurance for the CAR-T hub to be in Ghent Belgium!

Purpose: 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 built 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 Qualified Person, CAR-T Europe is responsible that product and process related investigations, complaints, batch review and release activities are accurately handled on time and in line with all ATMP/GMP requirements.

As a Qualified Person - QA, you will:


* Review and approve batch documentation to verify compliance with regulatory and company standards.

Release of incoming raw and starting materials and Final Drug Product release.


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


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

Raise issues that could have significant impacts on quality.


* Ensure that appropriate corrective and preventive actions (CAPAs) are identified an...