Senior Associate II, Quality Audits

• Support internal GMP/GDP and ISO 13485 audits across Europe and ROW as a contributing auditor.
• Assist in external audits of suppliers, contract manufacturers, contract laboratories, and service providers under guidance.
• 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.
• Collect and review documentation from external partners during audit activities.
• Communicate audit observations and follow-up expectations effectively.

• Bachelor of Science in Life Science, Engineering, or related technical discipline (advanced degree preferred).
• Minimum of 7 years experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum of 3 years progressive auditing experience, including leadership of complex, multi-country audits.
• Demonstrated expertise in EMA expectations, ISO 13485, and global GxP frameworks.
• Proficiency in English, both written and spoken.

• Advanced terminal degree (MD, PhD, PharmD) is desirable.
• Experience with inspection readiness activities.
• Strong interpersonal skills to facilitate collaboration across various teams.

Job Level: Professional Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.