QA Weekend Release Lead CAR-T (QP required)

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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Johnson & Johnson (J&J) is recruiting a QA Release Weekend Lead with a Qualified Person accreditation 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 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.

The QA Release Weekend Lead CAR-T is responsible to take part in and oversee the release activities which take place during the weekend shift i.e. release of batches in line with all ATMP/GMP requirements whilst adhering to the established turn around timelines. Additionally the function contributes to appropriate communication and hand-overs between the different work regimes (week and weekend shift).

This position will involve working in a weekend shift (6AM - 6PM) on site. This lead position will rotate between the locations in the Ghent facilities.

You will be responsible for:

• Batch Documentation Review/Release: Review and approve batch documentation to verify compliance with regulatory and company standards.

• Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR- T products. Provide QA oversight and guidance for manufacturing and logistics processes.

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

• 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.

• Collaboration and Stakeholder Engagement: Foster and maintain effective working relationships with internal teams business partners and external collaborators ensuring alignment with quality objectives and deliverables.

• Training and Coaching: Provide coaching and training to associates to ensure understanding and adherence to quality standards and GMP requirements

Flexibility in Working Hours: This function requires working in a weekend regime from 6 AM to 6 PM. And this position may involve flexible working hours depending on business requirements and/or hand-over needs.

Qualifications/Requirements:

• Educational Background: Certified Industrial Pharmacist with a EU Qualified Person accreditation is required.

• A degree in Pharmacy with at least 5 years of cross-functional experience in the pharmaceutical industry.

• Pharmaceutical Knowledge: In-depth understanding of pharmaceutical product development qualification packaging validation testing release and distribution processes.

• Regulatory Knowledge: Up-to-date knowledge of pharmaceutical legislation including current Good Manufacturing Practices (cGMP) and Advanced Therapy Medicinal Products (ATMP) regulations.

• Analytical and Decision-making Skills: Strong analytical thinking and decision-making abilities with a keen attention to detail.

• Communication Skills: Excellent verbal and written communication skills to effectively negotiate and interact with both external and internal customers and partners.

• Quality Systems Experience: Proven experience working with quality systems ensuring compliance with industry standards and regulatory requirements.

• Aseptic Processing Knowledge: Experience with aseptic processing and techniques is preferred with a solid understanding of the requirements for sterile manufacturing.

• Organizational Skills: Highly organized capable of managing multiple tasks in a team environment and able to work effectively under minimal supervision while maintaining a positive attitude.

• Effective Communication: Strong written and verbal communication skills with the ability to convey technical and regulatory information clearly.

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.

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