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 Systems **Job Category:** Professional **All Job Posting Locations:** Beerse, Antwerp, Belgium, 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 searching for the best talent for a Quality Systems Associate CAR-T 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, Janssen is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site. In this role you will be responsible for management and monitoring of the quality systems processes supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment. **As a Quality Systems Associate, you will:** + Own or support QSEs such as Event Management, Change Control, and Supplier Management for Carvykti. + Develop and document QSE processes in procedures and work instructions. + Act as site expert and trainer for QSE-related topics. + Conduct gap assessments and ensure process compliance. + Monitor and improve QSE performance across the CAR-T organization. + Serve as Trackwise/COMET key user: manage access, train users, and represent the site in global forums. + Ensure inspection readiness and alignment with J&J policies, cGMP, and quality standards. + Identify and implement process improvements to support Carvykti’s success. **Qualifications/Requirements:** + Graduate degree or higher in Science, Bioengineering, pharmacy or related field, or equal by experience + Strong understanding of the pharmaceutical environment, regulatory requirements and cGMP + Knowledge of the different quality processes and quality systems + Knowledge to perform investigations and risk analyses + Communicative skills to collaborate with different business partners (both **Dutch and English** ) + You have a quality mentality + You are flexible to support shifting priorities + You continuously look for improvements At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.   **Here’s what you can expect:**   + **Application review:** We’ll carefully review your CV to see how your skills and experience align with the role. + **Getting to know you:** If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have. + **Staying informed:** We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. + **Final steps:** For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.   Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! \#RPOEMEA