CAR-T QA Qualification Manager - EMEA

Biopharma Careers; Oost-Vlaanderen; Remote; EUR 80,000 - 138,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being programs

Job summary

Johnson & Johnson is recruiting a QA Qualification Manager for CAR-T Europe, based in Ghent, Belgium. You will lead the QA Qualification team, ensuring qualified state across facilities and equipment, and provide QA oversight for CAR-T expansion projects.

Role requires 5+ years in biopharma, strong regulatory knowledge and hands-on experience with cGMP. You will interact with Engineering, Maintenance, Operations and external partners to ensure compliance and continuous improvement.

Qualifications

• Bachelor’s degree in engineering, Life Sciences or equivalent.
• At least 5 years of relevant experience in biological/pharmaceutical industry; leadership experience.
• Knowledge of pharmaceutical legislation and cGMP requirements in clinical and commercial manufacturing.

Responsibilities

• Lead QA Qualification team for facilities, utilities and equipment across CAR-T units.
• Provide QA review/approval of qualification/validation deliverables and investigations.
• Serve as QA spokesperson during regulatory inspections and audits.

Skills

Quality leadership

QA oversight

Regulatory knowledge

cGMP

GMP practices

Risk-based decisions

Education

Bachelor’s degree in engineering or Life Sciences

Job description

Johnson & Johnson is recruiting a QA Qualification Manager for CAR-T Europe, based in Ghent, Belgium. You will lead the QA Qualification team, ensuring qualified state across facilities and equipment, and provide QA oversight for CAR-T expansion projects.

Role requires 5+ years in biopharma, strong regulatory knowledge and hands-on experience with cGMP. You will interact with Engineering, Maintenance, Operations and external partners to ensure compliance and continuous improvement.