Experienced Specialist, QA – Quality in the Plant

Location: Leiden, South Holland, Netherlands; onsite. The role initially follows a daytime schedule and transitions to a 16/7 shift organization with early shifts from 07:00–15:30 and late shifts from 15:00–23:30.

Salary: €53,500–€85,445 base pay annually, plus an annual bonus and benefits.

Company

Johnson & Johnson MedTech develops healthcare and pharmaceutical solutions intended to improve patient outcomes.

What you will do

• Provide real-time QA oversight and guidance across commercial and clinical manufacturing operations.
• Observe GMP and aseptic activities, conduct floor walks and GEMBA activities, and oversee critical process steps.
• Support initiation, triage, containment, escalation, investigations, operator interviews, and risk-based quality decisions.
• Review and approve GMP documentation, deviations, investigations, CAPAs, and change controls.
• Support inspection readiness, quality-system improvements, MES exception management, SAP-related quality processes, and material-status activities.
• Coach operators and operational leaders while collaborating with Operations, MSAT, Engineering, Warehouse, Quality Control, and Training.

Requirements

• Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or a related scientific field.
• At least 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.
• Strong knowledge of GMP regulations, pharmaceutical manufacturing, deviation management, CAPA, change control, and risk management.
• Strong communication, coaching, influencing, analytical, and problem-solving skills; awareness of responsible AI practices and effective prompting techniques.

Nice to have

• Experience supporting aseptic processing or biologics manufacturing operations.
• Experience with MES, SAP, and digital manufacturing systems.

Culture & Benefits

• Collaborative environment focused on learning, innovation, inclusion, and professional development.
• Opportunity to work directly with manufacturing teams and contribute to products that support patients.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and programs supporting financial, physical, and mental health.
• Service anniversary and recognition awards, insurance plans, and a performance-based annual bonus.