Senior Associate II, Quality Audits

Biogen; Baar; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Biogen is seeking a Senior Associate II in Quality Audits to support internal and external audits across Europe and ROW. The role focuses on ISO 13485 and other GxP frameworks, with documentation and follow-up managed under a Lead Auditor’s direction.

You will coordinate with site SMEs and Quality teams, review CAPAs, and help ensure inspection readiness while upholding Biogen’s quality commitments globally.

Qualifikationen

• Requires experience in regulated pharmaceutical/biotech/medical device environments.
• Minimum 3 years auditing experience including leadership of multi-country audits.
• Demonstrated expertise in EMA expectations and ISO 13485.

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, 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.

Kenntnisse

Quality auditing

Regulatory knowledge

GxP compliance

Cross-functional collaboration

Documentation

English proficiency

Ausbildung

Bachelor of Science in Life Science/Engineering

Jobbeschreibung

About This Role

As a Senior Associate II in Quality Audits, you will be an integral part of Biogen's Corporate Quality team, focusing on audits, vendor, and external partner oversight. This position is pivotal in supporting both internal and external quality audits across Europe and Rest-of-World operations. You will actively participate in audits conducted under ISO 13485 and other applicable GxP regulatory frameworks, including EMA and local health authority expectations. Your role is crucial in executing audit processes, documenting findings, and ensuring follow-up activities are completed under the direction of a Lead Auditor. Through your efforts, you will help uphold Biogen's commitment to quality and compliance, contributing significantly to our ability to deliver safe and effective products globally.

What You'll Do

• 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.

Who You Are

You are a meticulous individual with a keen eye for detail and a strong commitment to maintaining quality standards. Your ability to seamlessly collaborate with diverse teams and communicate effectively makes you an ideal fit for this role. You thrive in dynamic environments where you can apply your auditing expertise and problem solving skills to manage complex situations. Your passion for quality and compliance drives you to contribute positively to Biogen's mission of improving lives.

Required Skills

• 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.

Preferred Skills

• 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.