QA Qualification Manager, CAR-T EMEA

Description

The company is a healthcare business working across Innovative Medicine and MedTech. This role sits in its EMEA CAR-T programme.

The team is recruiting a QA Qualification Manager for the European CAR-T manufacturing hub in Gent, East Flanders, Belgium. The job is in Quality, Quality Assurance, at professional level.

CAR-T (chimeric antigen receptor T-cell) therapy uses a patient's own immune system. The patient's T cells are genetically engineered to recognise and destroy cancer cells that carry a specific antigen.

The company has set up two CAR-T manufacturing centres in the Ghent area. Quality Control laboratories operate from the existing site in Beerse.

You will lead the QA Qualification team. The team keeps facilities, utilities and production equipment in a qualified state across both manufacturing units and gives quality oversight to CAR-T expansion projects.

The role is accountable for quality oversight and for keeping the qualification and lifecycle management of facilities, utilities and production equipment compliant across the CAR-T units.

Responsibilities

• Be the main QA contact for Qualification, Maintenance and Engineering across the lifecycle of facilities, utilities and production equipment.
• Review and approve qualification and validation deliverables on time, including user requirements, risk assessments, validation plans, protocols, reports, investigations, CAPAs and change controls. Make sure they meet the required quality, technical and regulatory standards.
• Make sure deviations that could affect patient safety, product quality or product supply are assessed properly and escalated.
• Act as a key QA spokesperson and subject-matter expert during regulatory inspections, audits and partner meetings.
• Build the team's skills and encourage new ideas through coaching, training and external benchmarking.
• Lead the design and rollout of lasting improvements to organisational effectiveness, quality, compliance and operational performance.
• Build and keep good working relationships with J&J business and quality functions and with the collaboration partner Legend Biotech, so that work meets the quality requirements that apply.
• Carry out all work in line with safety policies, quality systems and cGMP requirements.

Requirements

• Bachelor's degree in engineering, life sciences or an equivalent technical discipline.
• At least 5 years of relevant experience in the biological or pharmaceutical industry, including managing people.
• Current, in-depth knowledge of pharmaceutical legislation and cGMP in clinical and commercial manufacturing, especially for cell therapy products.
• Strong analytical skills and sound risk-based decision-making and problem-solving.
• Clear written and verbal communication, including explaining complex quality and technical topics to varied audiences.
• Proven experience with pharmaceutical quality systems, including deviations, CAPAs, change control and qualification or validation documentation.
• Organised and collaborative, able to work independently while operating across functions in a fast-moving environment.
• Hands-on experience qualifying and managing the lifecycle 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 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.
• Able to synthesise complex information, present clear conclusions and deliver results through teamwork.
• Understands AI concepts and frameworks, including responsible and ethical AI practices, and has written effective prompts to improve efficiency and productivity.
• Preferred: an advanced degree.
• Preferred: experience in cell therapy, parenteral manufacturing, or clinical or commercial quality.
• Preferred: knowledge of Good Tissue Practices.
• Preferred skills: business alignment, coaching, collaboration, compliance management, continuous improvement, fact-based decision making, Good Manufacturing Practices (GMP), ISO 9001, process improvements, Quality Control (QC), Quality Management Systems (QMS), quality standards, quality validation, regulatory environment, Standard Operating Procedures (SOP), tactical thinking, technical credibility.

Conditions

The anticipated base pay range is €79,800.00 - €137,770.00.

The company treats each employee as an individual and values diversity and merit.

Benefits

• Beyond base pay, you may receive an annual bonus with a set target (a percentage of pay) that depends on pay grade and location. The actual amount depends on the performance of the employee and the company in the previous calendar year. Some roles earn sales commissions instead.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave and volunteer leave.
• Well-being reimbursement and programmes supporting financial, physical and mental health.
• Service anniversary and recognition awards.
• Insurance plans, with eligible dependents in some locations, subject to plan terms.
• Benefits information is for guidance only. Amounts and benefits can vary by location and may change.