Analyst 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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Johnson & 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 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 QA Associate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements. The QA associate 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. This role involves working closely with cross-functional teams, including Vein-to-Vein department, manufacturing and Regulatory affairs, to drive continuous improvement and support the development and commercialization of CAR T-cell therapies.

Batch Documentation Review/Release : 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. 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