Specialist Quality System & Compliance – CQV

Job Description

Are you looking for a highly independent, hands-on role at the intersection of Quality, Engineering, Validation, and Project Management? Join us a a:

Specialist Quality System & Compliance – CQV

Welcome to our team

Our production facilities in Boxmeer are part of our global Animal Health production network and manufacture and package animal health products according to Good Manufacturing Practice standards (GMP). Currently, we are investing in a new EU and FDA compliant manufacturing facility, which includes a Quality Control laboratory, in Boxmeer to bring our latest animal health innovations to market. Once the manufacturing facility is fully operational (expected in 2030), it will create about 80–100 FTE jobs. The facility will include dedicated warehouse, manufacturing, quality assurance, quality control and packaging & labeling teams to deliver high quality, compliant products.

About the role

As a Specialist Quality System & Compliance – CQV, you will play a key role in the delivery of a new state-of-the-art manufacturing facility. Acting as the Quality representative for commissioning, qualification and validation (CQV) activities, you will ensure that facilities, utilities, equipment and computerized systems are designed, qualified and maintained in compliance with global quality standards, EU GMP, FDA requirements and data integrity principles.

Working closely with Engineering, Automation, Manufacturing and Quality teams, you will provide independent Quality oversight throughout the project lifecycle and help build an inspection-ready operation that supports successful regulatory inspections and long-term commercial manufacturing.

Tasks and responsibilities include but are not limited to

• Act as the Quality Assurance representative for commissioning, qualification and validation (CQV) activities across facilities, utilities, manufacturing equipment and computerized systems.
• Review and approve validation strategies, qualification plans and key CQV deliverables,  (including URS, DQ, IQ, OQ and PQ documentation).
• Ensure compliance with EU GMP, FDA cGMP, Annex 11, Annex 15, CSV, data integrity requirements and company quality standards.
• Partner with Engineering, Automation and Operations teams to embed quality and compliance throughout the system lifecycle.
• Participate in risk assessments, design reviews, FATs, SATs and qualification activities, applying Quality by Design and risk-based validation principles.
• Provide Quality oversight for critical GMP utilities and systems, including HVAC, purified water, compressed gases, environmental monitoring and building management systems.
• Maintain and continuously improve the Validation Master Plan (VMP) and site validation framework.
• Review and approve deviations, investigations, CAPAs and change controls related to qualification and validation activities.
• Support supplier qualification, vendor oversight, regulatory inspections and internal audits.
• Ensure validation documentation remains complete, traceable and inspection-ready while driving continuous improvement initiatives across validation and compliance processes.
• Other tasks as required in the Quality Systems & Compliance team.

Your Profile

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, Life Sciences or a related discipline.
• At least 5-8 years of experience in Quality Assurance, Validation, Engineering Quality or Commissioning, Qualification & Validation within a GMP-regulated pharmaceutical or biotechnology environment.
• Proven experience with the qualification and validation of facilities, utilities, manufacturing equipment and computerized systems.
• Strong knowledge of European and FDA Good Manufacturing Practice requirements, data integrity principles, computerized system validation and industry best practices for commissioning and qualification.
• Experience supporting major capital investment projects, facility start-ups or the implementation of new manufacturing sites.
• Solid understanding of the validation lifecycle, including requirements documentation, risk assessments, equipment qualification protocols and validation reports.
• Strong stakeholder management and communication skills, with the ability to collaborate effectively across multidisciplinary project teams.
• A pragmatic, hands-on and quality-focused professional with the ability to make sound, risk-based decisions in a complex environment.
• Fluent in English; knowledge of Dutch or willingness to learn is an advantage.
• Available to work on-site in Boxmeer

What we offer