QA Qualification Manager, CAR-T EMEA

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Johnson & Johnson EMEA CAR-T is recruiting a QA Qualification Manager for its European CAR-T manufacturing hub, based in Ghent, Belgium.

CAR-T (chimeric antigen receptor T-cell) therapy is an innovative treatment approach that harnesses a patient's own immune system. A patient's T cells are genetically engineered to recognise and eliminate cancer cells expressing a specific antigen.

To support the CAR-T programme in EMEA, J&J has established two CAR-T manufacturing centres in the Ghent area, Belgium. Quality Control laboratories operate from the existing J&J site in Beerse.

The QA Qualification Manager, CAR-T Europe, is accountable for providing quality oversight and ensuring the compliant qualification and lifecycle management of facilities, utilities and production equipment across the CAR-T manufacturing units.

• Bachelor’s degree in engineering, Life Sciences or an equivalent technical discipline is required; an advanced degree is preferred.
• At least 5 years of relevant experience in the biological and/or pharmaceutical industry, including people leadership. Experience in cell therapy, parenteral manufacturing, or clinical and commercial quality is preferred.
• Current, in-depth knowledge of applicable pharmaceutical legislation and cGMP requirements in clinical and commercial manufacturing environments, particularly for cell therapy products; knowledge of Good Tissue Practices is an asset.
• Strong analytical, risk-based decision-making and problem-solving skills.
• Excellent written and verbal communication skills, with the ability to communicate complex quality and technical topics clearly to diverse stakeholders.
• Demonstrated experience working within pharmaceutical quality systems, including deviations, CAPAs, change control and qualification or validation documentation.
• Highly organised, collaborative and able to operate effectively in a dynamic, cross-functional environment with an appropriate level of autonomy.
• Hands-on experience with the qualification and lifecycle management of facilities, utilities and production equipment.
• Proven experience leading, coaching and developing a team of technical or quality professionals.
• Knowledge of aseptic processing in ISO 5 environments and the use of biosafety cabinets.
• Experience with data trending and statistical analysis to support risk-based decisions and continuous improvement.
• Strong stakeholder-management and influencing skills across Quality, Engineering, Maintenance, Operations and external partners.
• Ability to synthesise complex information, present clear conclusions and deliver results through team-based collaboration.

• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

Lead the QA Qualification team responsible for maintaining the qualified state of facilities, utilities and production equipment across both manufacturing units, while providing quality oversight for CAR-T expansion projects.

• →Act as the primary QA point of contact for Qualification, Maintenance and Engineering throughout the lifecycle of facilities, utilities and production equipment.
• →Provide timely QA review and approval of qualification and validation deliverables, including user requirements, risk assessments, validation plans, protocols and reports, as well as related investigations, CAPAs and change controls, ensuring appropriate quality and technical rigour and compliance with regulatory requirements.
• →Ensure deviations with potential impact on patient safety, product quality and/or product supply are appropriately assessed and escalated.
• →Serve as a key QA spokesperson and subject-matter expert during regulatory inspections, audits and partner engagements.
• →Build team capability and foster innovative thinking through coaching, training and external benchmarking.
• →Drive the development and implementation of sustainable improvements in organisational effectiveness, quality and compliance, and operational performance.
• →Establish and maintain effective working relationships with J&J business and quality functions and with collaboration partner Legend Biotech to ensure alignment with applicable quality requirements.
• →Perform all activities in accordance with applicable safety policies, quality systems and current Good Manufacturing Practice (cGMP) requirements.

If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing. You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.