QA Manager: Digital GMP & Operations Lead

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Flexible working arrangements

Global market leader

Dynamic and inspiring environment

Lead new team within Quality org

Exposure to biopharma manufacturing

International network of experts

Continuous professional development

Job summary

Johnson & Johnson Innovative Medicine in Leiden, the Netherlands, seeks a Manager Quality Assurance - Operational Commercial Products to lead a QA team ensuring GMP oversight for commercial manufacturing and its digital systems at the Leiden site.

You will collaborate with Operations, warehouse, QC labs, maintenance, and MSAT, providing leadership in quality governance for ERP/MES and validated computerized systems.

Qualifications

• Master's degree in a relevant scientific or technical discipline.
• Minimum six years' experience in quality/GMP environments, with at least two years in a managerial role.
• Strong quality mindset with risk-based judgment to defend decisions.
• Knowledge of QMS, cGMP, and pharma regulations (ICH, FDA, EMA).
• Knowledge of digitalization, BI, ERP, MES, and computerized system validation/qualification.
• Excellent written and spoken Dutch and English.
• Team player with ability to lead and make decisions when needed.
• Understanding of AI concepts and responsible AI practices.

Responsibilities

• Lead, coach, and develop a team of QA specialists (8-12).
• Serve as primary QA partner for Operations, Warehouse, QC Labs, Maintenance, and MSAT.
• Lead resolution of complex quality/compliance issues.
• Maintain and improve GMP processes for commercial manufacturing and testing.
• Provide quality oversight for digital/computerized systems.
• Support inspection readiness and manage regulatory inspections.

Skills

Six years experience

Quality mindset

Quality decisions

Dutch & English communication

Team leadership

AI concepts awareness

Cross-functional collaboration

Education

Master's degree in science/engineering

Tools

ERP systems

MES systems

Digital quality governance

Job description

Johnson & Johnson Innovative Medicine in Leiden, the Netherlands, seeks a Manager Quality Assurance - Operational Commercial Products to lead a QA team ensuring GMP oversight for commercial manufacturing and its digital systems at the Leiden site.

You will collaborate with Operations, warehouse, QC labs, maintenance, and MSAT, providing leadership in quality governance for ERP/MES and validated computerized systems.