Biogen is a biotechnology and healthcare company focused on researching, developing, and delivering treatments for serious neurological conditions. Its work spans diseases such as Alzheimer’s disease, multiple sclerosis, and spinal muscular atrophy, combining clinical research, scientific collaboration, and drug development to advance neurology. The company also emphasizes improving access to care and supporting greater equity in healthcare.
Principal Quality Auditor, GMP and ISO 13485
Lead complex GMP, ISO 13485, and global GxP audits for Biogen, a biotechnology company developing medicines. Oversee supplier audits, corrective actions, and inspection readiness.
Description
- Lead complex, high-risk internal GMP/GDP and ISO 13485 audits independently across Europe and other regions.
- Conduct for-cause audits of critical suppliers, contract manufacturers, and service providers.
- Use risk-based audit methods that account for regional regulatory requirements.
- Produce audit reports ready for regulatory inspection.
- Assess and approve CAPA responses to complex findings, and track remediation.
- Provide senior technical guidance and coach auditors during complex audits.
- Assist the Associate Director with the regional audit program, including coordinating schedules.
- Advise on regulatory engagements and inspection preparation.
- Mentor auditors and build the broader audit team's capabilities.
- Present critical findings and compliance gaps with appropriate senior-level context.
- Shape remediation plans and track resolution of significant quality issues.
Requirements
- Bachelor of Science in life sciences, engineering, or a related technical field.
- At least 13 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment for Principal level.
- At least 5 years of progressive audit experience, including leading complex, multi-country audits, for Principal level.
- Expertise in EMA expectations, ISO 13485, and global GxP frameworks.
- Fluent English for Principal level.
- Bachelor of Science in life sciences, engineering, or a related technical field for Senior Associate III level.
- At least 10 years of experience in a regulated pharmaceutical, biotechnology, or medical device environment for Senior Associate III level.
- At least 4 years of audit experience, including independent Lead Auditor responsibilities, for Senior Associate III level.
- Experience with ISO 13485 and global GxP regulatory frameworks, including FDA and EMA, for Senior Associate III level.
- English proficiency for Senior Associate III level.
- An advanced terminal degree such as an MD, PhD, or PharmD is preferred.
- Experience coaching and mentoring auditors is preferred.
- Additional language fluency is preferred.
- Experience with supplier qualification processes is preferred.
Benefits
- Stability and resources offered by an established biotechnology company.
- Opportunities to learn, grow, and broaden your skills.
- An inclusive workplace culture focused on belonging.