Senior Associate II – Quality Audits

About the role

As a Senior Associate II in Quality Audits, you will join Biogen's Corporate Quality team to support internal and external audits across Europe and the Rest‑of‑World. You will work under the guidance of a Lead Auditor to execute audit processes, document findings, and ensure follow‑up actions are completed.

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, documenting activities and preparing audit reports.
• Track audit responses and CAPAs, ensuring completeness and readiness for inspections.
• Collaborate with site SMEs and Quality teams to gather documentation and clarify audit observations.

Required profile

• Bachelor’s degree in Life Science, Engineering or related field (advanced degree preferred).
• Minimum 7 years experience in a regulated pharmaceutical, biotechnology or medical device environment.
• At least 3 years progressive auditing experience, including multi‑country audits.
• Strong communication skills in English, both written and spoken.

Required skills

• Expertise in ISO 13485 and global GxP frameworks.
• Knowledge of EMA expectations and other applicable regulatory requirements.
• Proficiency in conducting and documenting audits, CAPA tracking and inspection readiness activities.