Manager Quality Assurance (API)

Location: Geel, Antwerp, Belgium; onsite role supporting 24/7 manufacturing operations, including evening and weekend standby rotations.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across Innovative Medicine and MedTech.

What you will do

• Lead, coach, and develop QA professionals responsible for the timely release of commercial APIs.
• Act as the QA point of contact for the API production plant and provide quality oversight of manufacturing operations.
• Review and approve GMP documentation, including procedures, work instructions, batch records, protocols, and reports.
• Support Annual Product Reviews and approve Continued Process Verification reports for the commercial API portfolio.
• Manage deviations, non-conformances, CAPAs, change controls, and product quality complaints, escalating critical issues when required.
• Represent QA during Health Authority inspections and customer audits while partnering with Supply Chain to maintain reliable product supply.

Requirements

• Master’s degree in Chemistry, Bioengineering, Pharmaceutical Sciences, or a related scientific field.
• At least five years of experience in chemical or pharmaceutical supply chain and/or quality assurance.
• Proven experience as a Quality Release Responsible for commercial products.
• Strong knowledge of domestic and international cGMP requirements, ICH guidelines, and quality standards.
• Experience with Health Authority inspections, audit readiness, and regulatory interaction.
• Fluent Dutch and English, with strong communication, analytical, problem-solving, and risk-based decision-making skills.

Nice to have

• Formal or informal people leadership experience.
• Experience shaping Quality strategy and influencing cross-functional teams.
• Strong negotiation, partnership, presentation, and stakeholder management skills.

Culture & Benefits

• Inclusive work environment focused on individual contribution, diversity, and dignity.
• Opportunity to strengthen Quality and Compliance Culture across supporting departments.
• Focus on innovative thinking, benchmarking, and continuous improvement.
• Participation in an on-call rotation to support continuous production and timely quality decisions.