CQV Quality Systems Lead for New GMP Facility

MSD Animal Health Nederland; Boxmeer; On-site; EUR 100,000 - 150,000; Full time

Benefits offered by this job

Annual bonus

35.5 days paid leave

Solid pension scheme

Company restaurant

Job summary

MSD Animal Health Nederland in Boxmeer seeks a Specialist Quality System & Compliance – CQV to lead quality oversight during commissioning, qualification and validation for a new state‑of‑the‑art facility. You will ensure facilities, utilities, equipment and computerized systems meet EU GMP, FDA requirements and data integrity standards.

You will collaborate with Engineering, Automation, Manufacturing and Quality teams to deliver an inspection‑ready operation that supports regulatory inspections

Qualifications

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences or related discipline.
• At least 5–8 years of experience in Quality Assurance, Validation, Engineering Quality or Commissioning, Qualification & Validation within GMP environments.
• Proven experience with qualification and validation of facilities, utilities, equipment and computerized systems.

Responsibilities

• Act as the Quality Assurance representative for CQV activities across facilities, utilities, manufacturing 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, data integrity and company standards.
• Partner with Engineering, Automation and Operations to embed quality throughout the system lifecycle.
• Participate in risk assessments, design reviews, FATs, SATs and validation activities using QbD and risk-based validation.

Skills

Quality Assurance

Validation

Commissioning & Qualification

GMP

CSV

Regulatory inspections

Stakeholder management

Project management

Data integrity

Quality systems

Education

Bachelor’s or Master’s degree in Engineering / Life Sciences

Tools

Computerized systems validation

Job description

MSD Animal Health Nederland in Boxmeer seeks a Specialist Quality System & Compliance – CQV to lead quality oversight during commissioning, qualification and validation for a new state‑of‑the‑art facility. You will ensure facilities, utilities, equipment and computerized systems meet EU GMP, FDA requirements and data integrity standards.

You will collaborate with Engineering, Automation, Manufacturing and Quality teams to deliver an inspection‑ready operation that supports regulatory inspections