Job Description

Locations

• CHE - Lucerne - Schachen (Werthenstein)

Skills Required

• GMP-regulated biologics manufacturingintermediate
• GMP expectationsintermediate

Required Qualifications

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

Preferred Qualifications

• Current Employees apply HERE (experience)
• Current Contingent Workers apply HERE (experience)

Responsibilities

• End-to-End Compliance & Issue Resolution
• Lead and drive resolution of complex 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.
• Lead and drive resolution of complex 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.
• Change & Risk Management
• 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.
• 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.
• Operational Support & Decision Enablement
• 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.
• 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.
• Performance Management & Compliance Excellence
• 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 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.
• Inspection Readiness & Quality Systems
• 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.
• 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.
• Facility / Engineering Interface
• 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.
• 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.
• Project Leadership & Collaboration
• 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.
• 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.

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