QA Operations Manager – Digital Systems & Compliance

Johnson & Johnson Co.; 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

Opportunity to lead a new QA team

Exposure to biopharmaceutical tech

International quality & digital-expert

Job summary

Johnson & Johnson Leiden site seeks a Manager Quality Assurance - Operational Commercial Products to lead a QA team overseeing quality for commercial manufacturing and its digital systems in Leiden.

You will collaborate with Operations, Warehouse, QC Labs, Maintenance and MSAT, providing governance for ERP, MES, BI, and computerized systems while driving inspection readiness and regulatory readiness across the organization.

Qualifications

• Master's degree in a relevant scientific or technical discipline (biosciences, pharmacy, analytical chemistry, process technology, or engineering).
• Minimum of six years’ quality/GMP experience in pharma/consumer or medical device, with at least two years in a managerial role.
• Knowledge of cGMP, quality systems, and pharma regulations (ICH, FDA, EMA).
• Knowledge of digitalization, BI, ERP, MES, computerized system validation and qualification.
• Excellent written and spoken Dutch and English.

Responsibilities

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

Skills

Quality mindset

Risk-based judgment

Quality decisions

Communication skills (Dutch & English)

Team leadership

AI concepts awareness

Education

Master's degree in a relevant scientific or technical discipline

Tools

ERP systems

MES systems

Business Intelligence

Computerized system validation

Qualification processes

Job description

Johnson & Johnson Leiden site seeks a Manager Quality Assurance - Operational Commercial Products to lead a QA team overseeing quality for commercial manufacturing and its digital systems in Leiden.

You will collaborate with Operations, Warehouse, QC Labs, Maintenance and MSAT, providing governance for ERP, MES, BI, and computerized systems while driving inspection readiness and regulatory readiness across the organization.