QA Qualification Manager, CAR-T EMEA

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gent, East Flanders, Belgium

Job Description:

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.

Learn more at https://www.jnj.com/innovative-medicine

Janssen Pharmaceutica is recruiting a QA Qualification Manager, CAR-T EMEA

As a QA Qualification Manager, CAR-T EMEA:

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.

The responsibilities and the impact YOU will have:

Major Responsibilities:

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.

Key Responsibilities

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.

We would love to hear from YOU, if you have the following essential requirements:

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 env