Qualified Person (Biopharma)

Location: Sassenheim, Netherlands; onsite manufacturing site role

Salary: €88,400–€119,600 gross base salary per year, including 8% holiday allowance

Company

Johnson & Johnson MedTech develops healthcare and advanced therapy solutions across Innovative Medicine and MedTech.

What you will do

• Provide quality oversight for commercial and clinical advanced therapy products and lentiviral API manufacturing.
• Review investigations and non-conformances, assess product quality impact, and determine product disposition.
• Lead quality escalations, CAPA activities, change controls, risk assessments, and quality systems improvements.
• Review and approve critical quality documents, study protocols, reports, and document changes.
• Release drug substance lots and intermediates for global distribution, including clinical, validation, and emergency-use batches.
• Act as a quality subject matter expert during FDA, EMA, and other health authority inspections.

Requirements

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmaceutical Sciences, or a relevant field.
• Proven knowledge of the biotechnological, lentiviral, or pharmaceutical industry.
• Proficiency in English, both written and spoken.
• Deep understanding of global regulatory requirements, including cGMP, ICH, FDA, and EMA guidelines.
• Broad knowledge of QA systems, change control, deviation management, validation, manufacturing, laboratory processes, facilities, utilities, and technical automation.
• Ability to make independent, risk-based quality decisions and collaborate in a complex, fast-paced environment.

Nice to have

• Experience with Process Excellence, Co Think, or Kepner-Tregoe methods.
• Experience leading or supporting quality projects and developing colleagues through GMP training and coaching.

Culture & Benefits

• Inclusive work environment based on individual contribution, diversity, and dignity.
• Cross-functional collaboration with Operations, Quality Control, MSAT, Engineering, Warehouse, Development, and supply chain teams.
• Opportunity to influence quality and compliance culture through training, GEMBA walks, and continuous improvement initiatives.
• Role supports products intended for commercial and clinical use and global distribution.