Senior Quality Audit Specialist – ISO 13485 & GxP

Biogen, Inc.; Baar; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Biogen, Inc. is seeking a Senior Associate II in Quality Audits to join its Corporate Quality team. The role focuses on audits of internal processes and external partners across Europe and the Rest of World, under EMA, ISO 13485 and other GxP frameworks.

You will document findings and drive follow-ups under a Lead Auditor, contributing to Biogen’s commitment to safe and effective products globally. The successful candidate will bring strong auditing experience, English proficiency, and a

Qualifikationen

• Bachelor of Science in Life Science or related field (advanced degree preferred).
• 7+ years in a regulated pharmaceutical/biotechnology/medical device environment.
• 3+ years progressive auditing experience, including leadership of multi-country audits.
• Demonstrated EMA expectations, ISO 13485, and global GxP frameworks.

Aufgaben

• Support internal GMP/GDP and ISO 13485 audits across Europe and ROW as a contributing auditor.
• Assist in external audits of suppliers, contract manufacturers, CMOs, and service providers.
• Document audit activities and support preparation of audit reports and records.
• Track and review audit responses and CAPAs for completeness.
• Support inspection readiness activities and maintain audit documentation.
• Collaborate with site SMEs and Quality teams during audit execution to gather documentation and clarifications.
• Participate in supplier and partner audits to assess compliance with GxP and ISO 13485 requirements.

Kenntnisse

Auditing leadership

GxP knowledge

English proficiency

EMA/ISO13485 familiarity

Ausbildung

Life Science degree

Advanced degree preferred

Jobbeschreibung

Biogen, Inc. is seeking a Senior Associate II in Quality Audits to join its Corporate Quality team. The role focuses on audits of internal processes and external partners across Europe and the Rest of World, under EMA, ISO 13485 and other GxP frameworks.

You will document findings and drive follow-ups under a Lead Auditor, contributing to Biogen’s commitment to safe and effective products globally. The successful candidate will bring strong auditing experience, English proficiency, and a