QA Operations Leader, Digital Systems & Compliance

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 69,000 - 120,000; Full time

Benefits offered by this job

Flexible work

Global leader

Dynamic environment

Lead new team

Biopharma tech exposure

Job summary

Johnson & Johnson Innovative Medicine in Leiden is seeking a Manager Quality Assurance – Operational Commercial Products to lead a team of QA specialists and oversee quality for commercial manufacturing and its digital systems.

You will collaborate with Operations, Warehouse, QC labs, Maintenance and MSAT, ensuring GMP compliance, risk-based decision making and inspection readiness in a dynamic global health environment.

Qualifications

• Master’s degree in a relevant scientific or technical discipline.
• Minimum six years’ experience in quality and/or GMP environments; at least two years in a managerial role.
• Strong quality mindset with risk-based judgement and decision-making.
• Familiarity with quality systems, pharma regulations (ICH, FDA, EMA).
• Knowledge of digitalization, BI, ERP, MES, and computerized system validation.

Responsibilities

• Lead and coach a team of 8–12 QA specialists.
• Primary QA partner for Operations, Warehouse, QC Labs, Maintenance, and MSAT.
• Lead the 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 leadership

GMP knowledge

cGMP regulatory

Digital governance

BI/ERP/MES

Communication (Dutch/English)

Team development

Risk-based decision making

Cross-functional collaboration

Leadership

Education

Master’s degree in a relevant field

Job description

Johnson & Johnson Innovative Medicine in Leiden is seeking a Manager Quality Assurance – Operational Commercial Products to lead a team of QA specialists and oversee quality for commercial manufacturing and its digital systems.

You will collaborate with Operations, Warehouse, QC labs, Maintenance and MSAT, ensuring GMP compliance, risk-based decision making and inspection readiness in a dynamic global health environment.