About This Role
Associate Director of International Auditing – responsible for planning, executing, and overseeing quality audits across manufacturing sites, affiliates, contract manufacturers, suppliers, and service providers throughout Europe and the Rest of World (RoW). Based in Baar, Switzerland, this role reports to the Director of Quality Risk, Auditing and Governance and leads a team of auditors to maintain a risk‑based audit program aligned with global quality standards.
What You’ll Do
- Lead the planning and execution of a risk‑based audit program for internal manufacturing sites, affiliates, CMOs, suppliers, and service providers across Europe and RoW.
- Ensure audits are conducted in accordance with global quality policies, regulatory requirements, and industry standards.
- Oversee audit execution, including scope definition, auditor assignment, on‑site/remote activities, and reporting.
- Review and approve audit reports for quality, consistency, and accuracy.
- Ensure timely and effective response to audit observations, including corrective and preventive actions (CAPAs).
- Lead and develop a regional audit team of 4–7 direct reports, setting performance goals and providing coaching.
- Serve as the primary quality audit point of contact for European and RoW stakeholders.
- Drive continuous improvement of audit processes, tools, and metrics.
- Support regulatory inspections and due diligence activities as required.
- Collaborate with stakeholders to drive remediation and continuous improvement.
Who You Are
You are a strategic thinker with a passion for quality assurance and auditing. You possess strong leadership skills, enabling you to guide a team and foster collaboration across functions. Your ability to communicate clearly and manage complex situations drives audit excellence and compliance. You thrive in an international setting and are committed to maintaining high standards of product quality and patient safety.
Required Skills
- Bachelor’s Degree in Science, Engineering, Pharmacy, or related discipline required; advanced degree preferred or equivalent combination of education and experience.
- 12–15 years of experience in Quality Assurance and GxP auditing within the pharmaceutical or biotechnology industry.
- Minimum 5 years of people management experience and demonstrated leadership of complex, international audit programs.
- Experience auditing manufacturing sites, CMOs, suppliers, and service providers in global regulatory environments.
- Proficiency in English.
Preferred Skills
- Advanced terminal degree (MD, PhD, PharmD).
- Experience with ISO 13485 and global GxP regulatory frameworks (FDA, EMA).
Job Level
Management
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.
