CQV Quality Systems Leader — GMP & Validation

MSD Netherlands; Boxmeer; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

3% year-end bonus

Annual bonus

35.5 days paid leave

Travel allowance

Pension scheme

Development opportunities

Company restaurant

Excellent accessibility

Lyra Health mental well-being

Prayer/meditation room

Job summary

MSD Netherlands in Boxmeer seeks a Specialist Quality System & Compliance – CQV to lead QA oversight for commissioning, qualification and validation activities across facilities, utilities and systems, ensuring EU GMP and FDA compliance.

You will collaborate with Engineering, Automation and Operations to embed quality throughout the lifecycle and prepare an inspection-ready operation for regulatory inspections.

Qualifications

• 5–8 years of experience in Quality Assurance, Validation, Engineering Quality or Commissioning, Qualification & Validation within a GMP-regulated pharmaceutical or biotechnology environment.
• Strong knowledge of European and FDA GMP requirements, data integrity, and system validation.
• Experience supporting major capital investment projects, facility start-ups or new site implementations.

Responsibilities

• Act as Quality Assurance representative for CQV activities across facilities, utilities, equipment and computerized systems.
• Review and approve validation strategies, qualification plans and CQV deliverables (URS, DQ, IQ, OQ, PQ).
• Ensure compliance with EU GMP, FDA cGMP, Annex 11/15, CSV and data integrity requirements.
• Partner with Engineering, Automation and Operations to embed quality throughout the system lifecycle.
• Provide Quality oversight for critical GMP utilities and systems and maintain the Validation Master Plan.

Education

Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences or related

Job description

MSD Netherlands in Boxmeer seeks a Specialist Quality System & Compliance – CQV to lead QA oversight for commissioning, qualification and validation activities across facilities, utilities and systems, ensuring EU GMP and FDA compliance.

You will collaborate with Engineering, Automation and Operations to embed quality throughout the lifecycle and prepare an inspection-ready operation for regulatory inspections.