Head of Quality Assurance - Digital Systems & Operations

Johnson Johnson

Leiden

On-site

EUR 90,000 - 120,000

Full time

3 days ago
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Benefits offered by this job

Flexible working arrangements
Global market leader
Dynamic working environment
Lead a new QA team

Job summary

Johnson & Johnson Leiden seeks a Manager Quality Assurance - Operational Commercial Products to lead a team of QA specialists ensuring quality oversight of commercial manufacturing and the supporting digital systems at the Leiden site.

You will collaborate with Operations, warehouse, QC labs, maintenance, and MSAT, driving quality leadership, governance for ERP/MES, and qualification activities. Strong Dutch/English communication and six years GMP experience are required.

Qualifications

  • Master's degree in a relevant scientific or technical discipline.
  • Six years of quality/GMP experience with at least two years in a managerial role.
  • Knowledge of cGMP requirements and Quality Systems Pharma regulations (ICH, FDA and EMA).
  • Experience with digitalization, BI, ERP/MES and computerized system validation.

Responsibilities

  • Lead, coach, and develop a team of QA specialists (8-12).
  • Serve as the primary QA partner for Operations, Warehouse, 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
Risk-based judgment
Documentation & compliance
Dutch & English fluency
Digital systems knowledge
AI awareness
Stakeholder management
Team collaboration

Education

Master's degree in a relevant scientific or technical discipline

Tools

ERP systems
MES
Computerized System Validation

Job description

Johnson & Johnson Leiden seeks a Manager Quality Assurance - Operational Commercial Products to lead a team of QA specialists ensuring quality oversight of commercial manufacturing and the supporting digital systems at the Leiden site.

You will collaborate with Operations, warehouse, QC labs, maintenance, and MSAT, driving quality leadership, governance for ERP/MES, and qualification activities. Strong Dutch/English communication and six years GMP experience are required.

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