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Job Description:

Johnson & Johnson (J& J) is recruiting a QA Investigations Manager 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 constructed two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing J& J Beerse site. CAR-T investigational medicinal and commercial CAR-T products are manufactured in the Ghent facilities.

The successful candidate will be responsible for ensuring that the manufacturing processes meet quality standards and regulatory requirements. This role involves working closely with cross-functional teams, including Manufacturing Science and Technologies, Operations, Manufacturing and the Vein-to-Vein department.

The QA Investigations Manager, CAR-T will be reporting into the J& J QA CAR-T organization. The QA Investigations Manager CAR-T is responsible to execute QA investigation documentation reviews, to lead the QA investigation team and to manage the quality assurance activities pertaining to the investigations related to the CAR-T cell therapy manufacturing, ensuring compliance with regulatory standard.

Major Responsibilities:

• Quality Assurance Oversight: Monitor and ensure adherence to Good Manufacturing Practices (GMP/ATMP) and other relevant quality standards during the manufacturing of CAR T-cell products.
  
• Investigation and Compliance Expertise: Provide technical, quality, and compliance expertise to support thorough investigations of deviations, complaints, and other quality issues to ensure timely and effective resolution.
  
• Deviation & CAPA Management: Investigate deviations, non-conformances, and implement corrective and preventive actions (CAPAs) to ensure process integrity and product quality.
  
• CAPA Implementation: Identify and implement corrective and preventive actions (CAPAs) to address quality issues from investigations, particularly those affecting product quality and patient safety.
  
• Change Control: Evaluate and implement changes related to CAR T-cell processes, equipment, and materials, ensuring all changes comply with quality standards and regulatory requirements.
  
• Document Control: Review and approve GMP documents, including protocols, standard operating procedures (SOPs).
  
• Audits & Inspections Support: Prepare for and participate in internal and external audits and inspections. Lead audit response activities and implement corrective actions as necessary.

• Collaboration: Establish and maintain effective working relationships with the different business partners and Legend Biotech to ensure alignment of objectives and deliverables.

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

• Flexibility in Working Hours: The position may involve flexible working hours, depending on business requirements.

Experience and Skills:

• Education: Bachelor’s or Master’s degree in Pharmacy, Engineering, Biotechnology, or a related field.

• Experience: Minimum of 5 years of experience in quality assurance within the pharmaceutical or biotechnology industry. Experience with cell and gene therapy, specifically CAR-T, is preferred.

• Leadership: Develop, implement, and maintain QA strategies, policies, and procedures specific to job holders scope. Lead the team and provide coaching.

• Regulatory Knowledge: Strong understanding of regulatory requirements, including FDA, EMA, GMP/ATMP and ICH guidelines for CAR T-cell products.

• 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 partners.

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

Closing date: Tuesday, 23rd of September 2025.