Senior GMP Compliance & Quality Lead

MSD Malaysia; Luzern; Vor Ort; CHF 130.000 - 180.000; Vollzeit

Zusammenfassung

Merck & Co., Inc. is seeking a Compliance Excellence Lead (P3) at the Schachen site to drive GMP compliance and quality systems in biologics manufacturing.

You will lead investigations, CAPAs, risk assessments, and change controls while enabling inspection readiness and cross-functional collaboration with Manufacturing, Quality, Engineering, and MSAT. The role emphasizes independent execution, problem solving, project leadership, and coaching.

Qualifikationen

• Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
• Solid experience in GMP-regulated biologics manufacturing, quality systems, compliance, or 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

• End-to-End Compliance & Issue Resolution Lead for GMP deviations and CAPAs, with risk-based analysis.
• Change & Risk Management: support GMP product-related change controls and risk records.
• Operational Support: provide first-line compliance support for production troubleshooting and investigations.
• Performance Management: monitor KPIs and drive continuous improvement using quality tools.
• Inspection Readiness: support audits and regulatory inspections; participate as SME when required.
• Facility/Engineering Interface: provide compliance input to facility-related topics.
• Project Leadership: lead small to mid-scale compliance or quality improvement projects.

Kenntnisse

Compliance Activities

Compliance Monitoring

Deviation Management

GMP

Identifying Risks

Process Optimization

Quality Compliance

Regulatory Audits

Risk Assessments

Risk Avoidance

Standards Compliance

Ausbildung

Bachelor’s or Master’s in a scientific field

Jobbeschreibung

Merck & Co., Inc. is seeking a Compliance Excellence Lead (P3) at the Schachen site to drive GMP compliance and quality systems in biologics manufacturing.

You will lead investigations, CAPAs, risk assessments, and change controls while enabling inspection readiness and cross-functional collaboration with Manufacturing, Quality, Engineering, and MSAT. The role emphasizes independent execution, problem solving, project leadership, and coaching.