Senior QA Expert Audit Management 80-100%

In this role, you will own Health Authority inspections and customer audits across two Swiss sites, coordinating planning, execution, and post-audit follow-up. You will host inspectors, guide discussions, and ensure a smooth, professional audit experience. You’ll drive audit readiness with cross-functional teams, manage documentation and CAPA responses, and support ongoing GMP/QMS improvements in a dynamic growth environment.

• remote work up to 20%
• lifestyle benefits
• family benefits
• competitive salary
• inclusive workplace
• ethical culture

• Lead and coordinate Health Authority inspections and customer audits at Stein site and Basel QC lab from planning to post-audit follow-up
• Act as primary front-office representative during inspections, hosting inspectors and facilitating discussions
• Drive audit readiness by partnering with SMEs and cross-functional teams to prepare documentation, manage stakeholder communication, and support CAPA responses
• Oversee audit-related activities in TrackWise, including follow-up actions, compliance monitoring, and timely closure of commitments and corrective actions
• Contribute to continuous improvement of the Quality Management System by supporting GMP compliance initiatives, self-inspections, change controls, non-conformities, document management, and strategic growth projects

• Proven experience managing Health Authority inspections, including Swissmedic; FDA exposure is an advantage
• Fluent German and English communication skills
• Degree in a life sciences discipline such as Pharmacy, Chemistry, Biology, Biotechnology, or related field
• Strong knowledge of GMP requirements in pharmaceutical industry and experience driving inspection readiness
• Experience in sterile manufacturing environments and/or biologics manufacturing is highly desirable

• Diplomatic communication
• Stakeholder management
• Cross-functional collaboration
• TrackWise
• GMP compliance
• CAPA management