Principal Auditor, Quality Audits

About the role

As a member of the Corporate Quality team, you will lead and execute high‑risk internal and external quality audits across Europe and the Rest of World. Based in Baar, Switzerland, the role focuses on GMP/GDP, ISO 13485 and global GxP regulatory frameworks, ensuring inspection readiness and strong quality governance.

Key responsibilities

• Plan, lead and conduct complex internal GMP/GDP and ISO 13485 audits, as well as for‑cause external audits of critical suppliers and contract manufacturers.
• Apply advanced risk‑based auditing methodologies, incorporate regional regulatory nuances, and prepare inspection‑ready audit reports.
• Review, challenge and approve CAPA responses for complex findings, monitor remediation progress and influence remediation strategies.
• Serve as senior technical resource, coach auditors, mentor junior staff and support the Associate Director in executing the regional audit program.

Required profile

• Minimum 13 years experience in a regulated pharmaceutical, biotechnology or medical‑device environment (or 10 years for Senior Associate III level).
• Proven leadership of multi‑country, high‑risk audits and strong knowledge of EMA, FDA and other health‑authority expectations.
• Excellent communication skills, able to present findings to senior leadership and drive effective remediation.

Required skills

• Deep expertise in GMP, GDP, ISO 13485 and global GxP frameworks.
• Advanced risk‑based auditing methodology.
• Fluent English (additional languages a plus).