QA Release QP Delegate – Weekend CAR T

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QA Release QP Delegate Weekend CAR-T

Shift: Weekend (06:0018:00 on site)

We are searching for the best talent for a QA Release QP Delegate to be 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 patients 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 Operations and Quality Control.

Purpose: The QA Release QP Delegate (Weekend) supports and oversees quality and release activities during weekend CART manufacturing. The role ensures batches meet GMP/ATMP standards provides onthefloor QA oversight and helps maintain smooth operational flow while meeting turnaround timelines.

As a QP Delegate you will:

• Review and approve batch documentation to confirm compliance with regulatory and internal quality standards.
• Support timely batch release to ensure uninterrupted manufacturing and patient supply.
• Provide QA presence on the production floor during weekend operations.
• Ensure manufacturing and logistics activities align with GMP/ATMP requirements.
• Offer realtime quality guidance to operational teams.
• Support investigations into deviations complaints and quality issues.
• Contribute to the definition and followup of effective CAPAs.
• Assist with preparation and participation in internal and external audits and inspections.
• Maintain processes and documentation in an inspectionready state.
• Build collaborative relationships with internal teams and external partners (e.g. Legend Biotech).
• Communicate clearly and proactively to support alignment on quality expectations and timelines.

Working hours:

• Work weekend shifts (06:0018:00) with flexibility for handovers when required.
• Complete initial training on weekday day shifts before independently covering weekend operations.

Experience and Skills

• Educational background in Pharmacy Life Sciences or a related field.
• QP accreditation or Industrial Pharmacist certification is advantageous or minimum of 3 years experience in QA and other relevant responsibilities.
• Knowledge of pharmaceutical manufacturing validation testing packaging release or distribution processes.
• Proven understanding of cGMP; familiarity with ATMP regulations is a plus (training available).
• Strong analytical and problemsolving skills with high attention to detail.
• Effective written and verbal communication skills with the ability to interact confidently with crossfunctional teams.
• Experience working within pharmaceutical quality systems in a regulated environment.
• Exposure to aseptic or sterile manufacturing is helpful but not required.
• Strong organizational skills with the ability to manage multiple tasks independently and collaboratively.
• Positive proactive and solution based outlook.

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.

Heres what you can expect:

• Application review: Well carefully review your CV to see how your skills and experience align with the role.
• Getting to know you: If theres a good match youll 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 well 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. Were excited to learn more about you and wish you the best of luck in the process! #RPOEMEA

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