Senior QA Expert Audit Management

About the role

Lead and coordinate Health Authority inspections and customer audits across Lonza's Stein manufacturing site and Basel QC laboratory, ensuring successful execution from planning through post‑audit follow‑up. The role combines technical expertise, diplomatic communication and strategic problem‑solving to maintain continuous audit readiness.

Key responsibilities

• Plan, host and manage complex inspections and audits, acting as the primary front‑office representative.
• Partner with SMEs and cross‑functional teams to prepare documentation, manage stakeholder communication and support CAPA responses.
• Oversee audit‑related activities in TrackWise, ensuring timely closure of commitments and corrective actions.
• Contribute to continuous improvement of the Quality Management System, supporting GMP compliance, self‑inspections, change controls and strategic growth projects.

Required profile

• Proven experience managing Health Authority inspections, especially Swissmedic; FDA exposure is a strong advantage.
• Fluent in German and English with strong communication skills.
• Degree in Pharmacy, Chemistry, Biology, Biotechnology or related life‑science discipline.
• Strong knowledge of GMP requirements in the pharmaceutical industry.

Required skills

• GMP compliance
• TrackWise audit management
• Audit readiness and CAPA handling
• Experience in sterile or biologics manufacturing environments

What we offer

• Agile career and dynamic work culture
• Inclusive and ethical workplace
• Compensation programs that recognize high performance
• Competitive salary with lifestyle, family and leisure benefits