Experienced Specialist, QA – Quality in the Plant

About the role

Johnson & Johnson Innovative Medicine in Leiden is hiring three Experienced Specialists, QA for its Quality in the Plant team. You will provide proactive, real-time quality assurance support within manufacturing operations, working closely with Operations and other site partners to strengthen GMP compliance, support investigations and deviations, and guide quality during manufacturing. The role starts on a daytime schedule and then moves to a 16/7 shift pattern (early shift 07:00–15:30, late shift 15:00–23:30).

Key responsibilities

• Maintain an active QA presence on the shop floor during assigned shifts, observe critical GMP and aseptic operations, conduct floor walks and GEMBA activities, and supervise compliance with procedures, data integrity, contamination control and cleanroom behaviour.
• Support manufacturing teams with quality guidance, assess quality events, take part in investigations and help with escalation and risk management.
• Support inspection readiness, quality culture initiatives and continuous improvement.
• Review and approve GMP documentation, investigations, deviations, CAPAs and change controls within your scope, and take part in quality risk assessments and root cause investigations.
• Take part in daily operational meetings, tier discussions and shift handovers, and support MES exception management, material status, SAP quality processes and Q-labeling.
• Coach operators and operational leaders on quality expectations and GMP requirements.

Required profile

• Bachelor's degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences or another relevant scientific field.
• Minimum 6 years of experience in a GMP-regulated environment with a bachelor's degree, or 4 years with a master's degree.
• Experience in Quality Assurance, Manufacturing Operations, Quality Control or related pharmaceutical functions.
• Experience leading investigations, quality risk assessments and compliance-related decisions.
• Aseptic processing or biologics manufacturing experience strongly preferred.

Required skills

• Strong understanding of GMP and pharmaceutical manufacturing processes.
• Deviation management, CAPA, change control and risk management systems.
• Communication, coaching and influencing skills; risk-based quality decisions.
• Preferred: MES, SAP and digital manufacturing systems.
• Preferred: understanding of AI concepts and frameworks.

What we offer

• Base pay of EUR 55,000 to EUR 86,710, including an 8% holiday allowance.
• Annual bonus, vacation days, parental leave of at least 12 weeks, bereavement and caregiver leave, well-being reimbursement and insurance plans.
• Collaborative environment with opportunities to learn and develop.