Quality Control SME - GMP, CAPA & Lab Systems

MSD Netherlands; Boxmeer; On-site; EUR 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salary

3% year-end bonus

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

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.