GMP Compliance Lead: Investigations, CAPA & Risk

MSD; Luzern; Vor Ort; CHF 120.000 - 170.000; Vollzeit

Zusammenfassung

MSD in Switzerland (Schachen site) is seeking an experienced compliance professional to lead GMP deviation resolution, change controls, and risk management within manufacturing. The role emphasizes cross-functional collaboration with Manufacturing, Quality, Engineering and MSAT, ensuring inspection readiness and robust CAPA definitions.

Fluent German and English are required. Responsibilities include leading investigations, evaluating risks, guiding improvements, and ensuring timely, compliant

Qualifikationen

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Solid experience in GMP-regulated biologics manufacturing, quality systems, compliance, technical operations, or a related area.
• Proven ability to solve complex problems and lead investigations with minimal guidance.
• Strong knowledge of GMP expectations, quality systems, documentation standards, and risk-based decision-making.
• Experience working cross-functionally with Manufacturing, Quality, Engineering, and MSAT.
• Ability to lead projects or workstreams and influence stakeholders within assigned scope.
• Strong communication skills in German and English.

Aufgaben

• Lead and drive resolution of GMP deviation records, investigations, impact assessments, and CAPAs within area of responsibility, ensuring timely and high-quality closure.
• Apply risk-based thinking and sound GMP judgment to analyze and resolve non-standard issues.
• Lead or significantly contribute to robust root cause analysis and sustainable CAPA definition.
• Escalate complex or high-risk topics with clear recommendations.
• Manage and support GMP product-related change controls and risk records, ensuring compliant and efficient execution.
• Apply quality risk management principles to manufacturing, technical, and facility topics.
• Provide input into risk assessments, change strategies, and implementation plans.
• Ensure documentation tasks and compliance deliverables are actively controlled through completion.
• Provide first-line compliance support for production troubleshooting, investigations, and cross-functional alignment.
• Support Manufacturing teams in resolving operational issues while maintaining GMP compliance.
• Interpret partner and customer needs and translate them into practical, compliant solutions.
• Enable timely decision-making by preparing options, recommendations, and risk-based assessments.
• Support monitoring and tracking of KPIs related to quality, compliance, and operational performance.
• Use data and trend analysis to identify risks, recurring issues, and improvement opportunities.
• Drive continuous improvement through operational excellence tools such as Gemba, 5S, and structured problem solving.
• Identify and implement improvements within area of responsibility.
• Support ongoing inspection readiness, including compliance of GMP documentation, deviations, investigations, and changes.
• Participate in preparation for internal audits, external audits, and regulatory inspections.
• Represent the functional area during audits or inspections as subject matter expert when required.
• Help strengthen inspection-ready behaviors and compliant execution within assigned areas.
• Perform GMP impact assessments related to facility, equipment, and engineering changes within assigned scope.
• Collaborate with Engineering and Facility Management to ensure compliant project execution and operational readiness.
• Provide compliance input to technical and facility-related topics impacting manufacturing operations.
• Lead small to mid-scale compliance or quality improvement projects with minimal to moderate complexity.
• Act as project lead or workstream lead, coordinating cross-functional contributors and tracking milestones.
• Build strong working relationships across Manufacturing, Quality, Engineering, and MSAT.
• Coach and guide junior team members and support knowledge sharing across the group.

Kenntnisse

GMP knowledge

Problem solving

Cross-functional collaboration

Communication skills (German & English

Ausbildung

Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline

Jobbeschreibung

MSD in Switzerland (Schachen site) is seeking an experienced compliance professional to lead GMP deviation resolution, change controls, and risk management within manufacturing. The role emphasizes cross-functional collaboration with Manufacturing, Quality, Engineering and MSAT, ensuring inspection readiness and robust CAPA definitions.

Fluent German and English are required. Responsibilities include leading investigations, evaluating risks, guiding improvements, and ensuring timely, compliant