Senior Associate II, Quality Audits

About the role

Biogen is seeking a Senior Associate II to join its Corporate Quality team, focusing on internal and external quality audits across Europe and the Rest‑of‑World. The role supports ISO 13485, GMP/GDP, and other GxP audit activities, ensuring compliance and follow‑up under the guidance of a Lead Auditor.

Key responsibilities

• Support internal GMP/GDP and ISO 13485 audits across Europe and ROW as a contributing auditor.
• Assist in external audits of suppliers, contract manufacturers, laboratories and service providers.
• Document audit activities, prepare audit reports and track CAPA responses.
• Collaborate with site SMEs and Quality teams to gather documentation and clarify findings.

Required profile

• Bachelor’s degree in Life Science, Engineering or related field (advanced degree preferred).
• Minimum 7 years experience in a regulated pharma/biotech/medical‑device environment.
• At least 3 years progressive auditing experience, including multi‑country audits.
• Strong attention to detail and ability to work with diverse teams.

Required skills

• ISO 13485 audit methodology.
• GxP regulatory frameworks (GMP, GDP, EMA expectations).
• Auditing and CAPA management.
• Proficiency in English (written and spoken).