Quality Control Support Specialist
MSD Netherlands
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Benefits offered by this job
Job summary
MSD Netherlands is building a new Quality Control organization in Boxmeer. The Quality Control Support Specialist will act as a senior technical expert, ensuring GMP compliance, leading investigations, CAPA, and quality system improvements while collaborating across functions to support the new facility.
You will drive lab operations, qualification/validation, and digitalization initiatives, mentoring others and participating in audits and management reviews.
Qualifications
- Bachelor's degree in Life Sciences or related field.
- 4–6 years in GMP-regulated pharma, biotech, or life sciences.
- Proven track record of cross-functional project leadership.
- Strong GMP knowledge, quality systems, investigations, CAPA, change control.
- Experience with LIMS, SAP, and laboratory systems.
- Excellent written and spoken English; Dutch proficiency is a plus.
Responsibilities
- Act as SME for GMP compliance, quality systems, investigations, and CAPA.
- Lead complex deviations, root cause analyses, and CAPA activities.
- Own and drive change controls and quality system processes.
- Review GMP documentation: SOPs, protocols, validation docs, reports.
- Ensure laboratory operations meet procedures, standards and audits.
- Lead qualification, validation, calibration of lab equipment and systems.
- Drive continuous improvement, digitalization, and efficiency projects.
- Provide expert support to QA, Manufacturing and stakeholders.
- Monitor data, trends, and metrics; translate insights into actions.
- Lead cross-functional projects, mentor colleagues, and support audits.
Job description
This is a unique opportunity to help build a new Quality Control organization from the ground up, combining technical expertise, innovation, and leadership to support the future of animal health manufacturing in Boxmeer. Join us as 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 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.
This is a unique opportunity to help build a new Quality Control organization from the ground up, combining technical expertise, innovation, and leadership to support the future of animal health manufacturing in Boxmeer. Join us as 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 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.
The Quality Control Support Specialist is a senior technical expert within the Quality Control organization, playing a key role in ensuring GMP compliance, driving continuous improvement, and supporting operational excellence. Acting as a trusted Subject Matter Expert, you will collaborate across functions to strengthen quality systems, support inspection readiness, and contribute to the successful establishment and growth of the new Boxmeer West manufacturing facility.
- Act as the Quality Control Subject Matter Expert (SME) for GMP compliance, quality systems, stability studies, LIMS implementation, and laboratory equipment lifecycle management.
- Lead complex investigations, deviations, root cause analyses, and CAPA activities, ensuring timely and effective resolution.
- Own and drive quality system processes, including change controls, investigations, CAPAs, and compliance-related initiatives.
- Review and approve GMP documentation, including SOPs, protocols, validation documents, technical reports, and work instructions.
- Ensure laboratory operations comply with site procedures, global standards, and regulatory requirements, maintaining inspection readiness at all times.
- Lead and support qualification, validation, calibration, and implementation activities for laboratory equipment, systems, and new technologies.
- Drive continuous improvement, digitalization, automation, and efficiency projects across Quality Control and cross-functional teams.
- Provide expert support to laboratory operations, Quality Assurance, Manufacturing, and other stakeholders on quality and compliance matters.
- Monitor laboratory data, trends, and performance metrics, translating insights into actions that enhance quality, compliance, and operational excellence.
- Lead cross-functional projects, mentor colleagues, deliver GMP training, and represent Quality Control during audits, inspections, and management reviews.
- Bachelor’s degree in Life Sciences, Chemistry, Microbiology, Biotechnology, Pharmaceutical Sciences or a related field.
- At least 4-6 years experience in a GMP-regulated pharmaceutical, biotechnology or life sciences environment.
- Proven track record of leading cross-functional projects and driving continuous improvement initiatives.
- Strong knowledge of GMP regulations, quality systems, investigations, CAPA management, change control, qualification and validation processes.
- Solid understanding of Quality Control laboratory operations, analytical methods and regulatory expectations.
- Experience working with LIMS, SAP, computerized laboratory systems and digital quality management platforms.
- Strong analytical and problem-solving skills, with experience in data analysis, trending and performance monitoring.
- Excellent project management, stakeholder management and influencing skills, with the ability to drive change across functions.
- Demonstrated leadership, coaching and mentoring capabilities, combined with strong technical writing and presentation skills.
- Excellent verbal and written communication skills in Dutch and English.
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
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