Qualified Person (Mgr.) (MedTech)

Location: Sassenheim, Netherlands; onsite manufacturing-site role.

Salary: €88,400–€119,600 gross annually, including an 8% holiday allowance.

Company

Johnson & Johnson MedTech develops healthcare solutions and manufactures commercial and clinical advanced therapy products, including lentiviral products.

What you will do

• Provide QA oversight for the manufacture of commercial and clinical advanced therapy products and lentiviral drug substances.
• Review investigations, non-conformances, product impact assessments, root-cause analyses, and product disposition decisions.
• Release drug substance lots, intermediates, clinical materials, validation batches, and emergency-use batches for global distribution.
• Approve CAPAs, change controls, protocols, reports, critical quality documents, and high-risk global changes.
• Lead quality escalations, risk assessments, GMP training, and quality-system improvement initiatives.
• Act as quality SME and Qualified Person during FDA, EMA, and other health-authority inspections.

Requirements

• Bachelor’s degree or higher in biochemistry, biology, pharmacy, or a relevant discipline.
• Proven knowledge of the biotechnological, lentiviral, or pharmaceutical industry.
• Proficiency in English, both spoken and written.
• Deep understanding of global regulatory and GMP requirements, including ICH, FDA, and EMA guidelines.
• Broad knowledge of QA systems, including change control, deviation management, validation, manufacturing, laboratory processes, facilities, utilities, and technical automation.
• Ability to make independent, pragmatic quality decisions, assess risk, and escalate critical issues in a complex environment.

Nice to have

• Experience with Process Excellence, Co Think, or Kepner-Tregoe methods.
• Knowledge of ISO 9001, quality validation, SOPs, and quality management systems.

Culture & Benefits

• Inclusive work environment focused on dignity, diversity, and individual contribution.
• Annual performance bonus with a target determined by pay grade and location.
• 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.
• Eligibility for insurance plans, service anniversary awards, and recognition programs according to applicable plans.