CAR-T QA Qualification Manager – Europe/EMEA

Johnson & Johnson Co.; Destelbergen; On-site; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson, headquartered in the Ghent area, is seeking a QA Qualification Manager for CAR‑T Europe. You will lead qualification across facilities, utilities and equipment, ensuring regulatory compliance and lifecycle management for CAR‑T projects.

The role demands deep knowledge of cGMP, risk assessments, validation deliverables and cross‑functional leadership to support patient‑centered cell therapies in Europe. Join a team delivering innovative medicines with global impact.

Qualifications

• 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.
• Knowledge of applicable pharmaceutical legislation and cGMP requirements in clinical and commercial manufacturing environments.

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.
• Act as the primary QA point of contact for Qualification, Maintenance and Engineering throughout the lifecycle of facilities, utilities and production equipment.
• Provide QA review and approval of qualification and validation deliverables, including risk assessments, validation plans, protocols and reports, ensuring regulatory compliance.

Skills

Quality Assurance

GMP

Regulatory Knowledge

Leadership

Data analysis

Stakeholder management

Problem solving

Education

Bachelor’s degree in engineering, Life Sciences or equivalent

Tools

cGMP

SOPs

Job description

Johnson & Johnson, headquartered in the Ghent area, is seeking a QA Qualification Manager for CAR‑T Europe. You will lead qualification across facilities, utilities and equipment, ensuring regulatory compliance and lifecycle management for CAR‑T projects.

The role demands deep knowledge of cGMP, risk assessments, validation deliverables and cross‑functional leadership to support patient‑centered cell therapies in Europe. Join a team delivering innovative medicines with global impact.