GMP Quality Control SME - Lead CI & Lab Excellence

MSD Malaysia; Boxmeer; On-site; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Competitive salary

3% year-end bonus

35.5 days paid leave

Travel allowance

Pension scheme

In-house company restaurant

Parking access

Sports membership contribution

Private park on site

Lyra Health mental well-being support

Prayer and meditation room

Extensive development opportunities

Growth-oriented workplace

Job summary

Merck & Co., Inc. invites applications for a Quality Control Support Specialist in Boxmeer to help build a new QC organization aligned with GMP. You will drive quality systems, investigations, CAPA, and lab lifecycle management, collaborating across functions to ensure inspection readiness.

You will lead qualification, validation, and digitalization efforts, provide expert QC support to QA, Manufacturing and other stakeholders, and mentor colleagues in a rapidly expanding site.

Qualifications

• Experience in GMP-regulated pharmaceutical or life sciences environments.
• Strong knowledge of GMP regulations, quality systems, investigations, CAPA management, change control, qualification and validation processes.
• Experience with LIMS, SAP, and digital quality management platforms.
• Excellent analytical and problem-solving skills.
• Strong project management and stakeholder management abilities.
• Excellent verbal and written communication skills in Dutch and English.

Responsibilities

• Act as the Quality Control 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.

Skills

GMP compliance

CAPA management

Change control

Investigations

Quality systems

Data analysis

Education

Bachelor’s degree in Life Sciences or related field

Tools

LIMS

SAP

Digital quality management platforms

Computerized laboratory systems

Job description

Merck & Co., Inc. invites applications for a Quality Control Support Specialist in Boxmeer to help build a new QC organization aligned with GMP. You will drive quality systems, investigations, CAPA, and lab lifecycle management, collaborating across functions to ensure inspection readiness.

You will lead qualification, validation, and digitalization efforts, provide expert QC support to QA, Manufacturing and other stakeholders, and mentor colleagues in a rapidly expanding site.