QA CAR-T Qualification Lead EMEA

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Johnson & Johnson Innovative Medicines is recruiting a CAR-T QA C&Q Lead Engineer for the CAR-T hub in Europe.

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 started up two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are operated from the existing J&J Beerse site.

As the CAR-T Qualification lead you will play a pivotal role in ensuring the qualification of critical systems equipment facilities and utilities used in CAR-T Manufacturing. You will lead a team of QA C&Q engineers and collaborate cross functionally with engineering maintenance validation and operation teams to ensure all systems and processes meet global GMP and regulatory expectations.

Job Responsibilities

The preferred candidate will:

• Lead a team of CAR-T QA Qualification Engineers and coordinate all QA Qualification activities related to qualification (IQ/OQ/PQ) of equipment facilities and utilities.

• Review and approve qualification documents such as change controls master documents protocols reports rationales SOPs URS IA & QSRs and related GMP documentation such as calibration rationales calibration master forms and completed calibration records master data set-up maintenance plans.

• Review and approval of data integrity deliverables such as system audit trail and user access reviews.

• Ensure that deviations related to equipment issues with possible impact on quality and/or compliance are evaluated thoroughly investigated and that adequate corrective and/or preventive actions are defined and implemented

• Ensure risk assessments (e.g. FMEA) are appropriately conducted and documented.

• Serve as QA representative during internal and external audits and regulatory inspections.

• Support the implementation and continuous improvement of SOPs and work instructions related to qualification.

• Collaborate cross functionally with the MAM (make asset management) and E&PS (engineering and property services) department and provide QA guidance during equipment and process lifecycle management including control of changes.

• Train and support team members and stakeholders in qualification and GMP compliance topics.

• Participate in system and process improvement / optimization projects and assure quality and compliance aspects and maintain a current knowledge of international regulations guidelines and industry practices and become the QA process expert.

• Support in defining qualification project schedules keeps quality oversight of qualification activities and makes sure milestones are met in a compliant manner.

• Escalate to management in a timely manner when required.

Qualifications

The candidate should have to following proficiencies:

• Masters degree in engineering with chemistry or analytical background or in pharmaceutical sciences.

• At least 5 years of relevant QA or Qualification experience in a GMP regulated pharmaceutical or biotechnology environment.

• Deep understanding of cGMP regulations such as (EU GMP Annex 1 PART IV ICH 21 CFR Part 11).

• Strong communication skills in English (written and verbal).

• affinity with computerized systems System parameter configurations and data management in critical production assets.

• ability to show and apply strong communication skills and are known as a great teammate who can work cross departmental in a continuous changing environment.

• Strong analytical thinking risk assessment and communication skills.

• Collaboration and teaming skills.
  

What is in it for you

You will be part of an enthusiastic team that has a strong quality focus on technology qualification automation and continuous improvement. Employees are very valuable to our organization and development is a daily responsibility. Through on the job training e-learning implementation of various projects and programs we ensure personal growth by focusing on your talents. We offer you a contract of indefinite duration with an attractive salary package including extra-legal benefits such as meal vouchers additional pension plan and hospitalization insurance.

Application Process

Interested You can apply for the position by filling in the application form on our website! Based on this we select the candidates for a first review.
Please apply by Monday 5th of January 2026.

Equal Opportunity Statement

The employers of the Johnson & Johnson family value diversity and inclusion. We are committed to building diverse teams that reflect both the patients and the partners we support. We strive to create an inclusive work environment where our people feel at home and are given the space to realize their full potential.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

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