Specialist Quality System & Compliance – CQV
Merck Gruppe - MSD Sharp & Dohme
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Benefits offered by this job
Job summary
Merck Sharp & Dohme LLC is seeking a Specialist Quality System & Compliance – CQV for our Boxmeer facilities. You’ll lead QA oversight during commissioning, qualification and validation of facilities, utilities and computerized systems to ensure inspection readiness and ongoing compliance.
You will collaborate with Engineering, Automation and Manufacturing teams across the lifecycle, support regulatory inspections, and drive continuous improvements to the Validation Master Plan and related
Qualifications
- Bachelor’s or Master’s degree in a related field.
- 5–8 years in QA, Validation, Engineering Quality or CQV within GMP environments.
- Proven experience with qualification and validation of facilities, utilities, equipment and computerized systems.
- Strong knowledge of EU GMP and FDA cGMP requirements and data integrity.
- Experience supporting major capital projects, facility startups or new sites.
- Fluent in English; Dutch knowledge is a plus.
Responsibilities
- Act as QA representative for CQV activities across facilities, utilities, equipment and computerized systems.
- Review and approve validation strategies and key CQV deliverables (URS, DQ, IQ, OQ, PQ).
- Ensure compliance with EU GMP, FDA cGMP, Annex 11/15, CSV and data integrity.
- Partner with Engineering, Automation and Operations to embed quality throughout the lifecycle.
- Provide Quality oversight for risk assessments, design reviews, FATs, SATs and qualification activities.
- Maintain and improve the Validation Master Plan and site validation framework.
- Support supplier qualification, regulatory inspections and internal audits.
- Manage deviations, investigations, CAPAs and change controls related to qualification and validation.
Skills
Education
Tools
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:
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 EUand 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.
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.
- 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.
- 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
The opportunity to step into a new, hands‑on position where you’ll work independently, collaborate across functions and take on real leadership responsibilities. Our benefits are very competitive, and the summary below will give you an idea of what you can expect.
- Competitive salary based on your knowledge and experience.
- 3% year-end payment and an annual bonus based on personal and company performance.
- At least 35.5 days of paid leave.
- Travel allowance and a solid pension scheme.
- A workplace within an organization that is continuously growing and evolving.
- Extensive development opportunities thanks to the size of the site and the presence of many disciplines and global departments represented in Boxmeer.
- A high-quality company restaurant offering fresh and healthy options daily.
- Excellent accessibility: the train station is located directly at our main entrance and there is ample parking available.
- A contribution toward your personal sports membership to support your vitality.
- A beautiful private park on the premises, ideal for a walk, break, or moment of relaxation.
- Mental well‑being support through Lyra Health for you and your family members.
- Access to a dedicated prayer and meditation room.
Our Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well‑being, and performance of animals and the people who care for them. We are a global team of professionals working together to make a positive difference in animal care and the world’s food supply and have a deep sense of responsibility towards our customers, consumers, animals, society, and our planet.
Through our commitment to The Science of Healthier Animals®, we offer veterinarians, farmers, pet owners and governments one of the widest ranges of veterinary pharmaceuticals, vaccines and health management solutions and services as well as an extensive suite of digitally connected identification, traceability and monitoring products. We invest in dynamic and comprehensive R&D resources and a modern, global supply chain. We are present in more than 50 countries, while our products are available in some 150 markets.
Please send an email including the vacancy number and job title to the following email address: RecruitmentNL@MSD.com. Applications can only be submitted through our career site.
Required Skills: cGMP Regulations, Equipment Qualification, GMP Compliance, Manufacturing, Operational Qualification, Quality Management Systems (QMS), Root Cause Analysis (RCA), Validation Activities
Preferred Skills: Pharmaceutical Industry
Current Employees apply HERE
Current Contingent Workers apply HERE
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Regular
Not Applicable
09/8/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R413219
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