Principal Auditor, Quality Audits

Biogen; Baar; Vor Ort; CHF 140.000 - 190.000; Vollzeit

Zusammenfassung

Biogen is seeking a Principal Auditor, Quality Audits, based in Baar, Switzerland. You will independently plan, lead, and execute high-risk GMP/GDP and ISO 13485 audits across Europe and Rest of World, including for-cause external audits of suppliers and contract manufacturers.

The role emphasizes regulatory expectations, inspection readiness, and coaching of auditors, with a pathway to Senior Associate III depending on experience.

Qualifikationen

• Bachelor of Science in Life Science, Engineering, or related technical discipline.
• Minimum of 13+ years experience in a regulated pharmaceutical, biotechnology, or medical device environment.
• Minimum of 5+ years progressive auditing experience, including leadership of complex, multi-country audits.
• Demonstrated expertise in EMA expectations, ISO 13485, and global GxP regulatory frameworks.
• Fluent in English.

Aufgaben

• Independently plan, lead, and execute complex, high-risk internal GMP/GDP and ISO 13485 audits across Europe and Rest of World.
• Lead and execute for-cause external audits of critical suppliers, contract manufacturers, and service providers.
• Apply advanced risk-based auditing methodologies incorporating regional regulatory nuances.
• Prepare inspection-ready audit reports.
• Review, challenge, and approve CAPA responses for complex findings, and monitor remediation progress.
• Serve as a senior technical resource and coach auditors during execution of complex audits.
• Support the Associate Director in executing the regional audit program, including audit schedule coordination.
• Provide expert input for regulatory interactions and inspection readiness.
• Mentor auditors and contribute to strengthening overall audit capability.
• Communicate critical findings and compliance gaps with senior-level context.
• Influence remediation strategies and monitor resolution of significant quality issues.

Kenntnisse

Auditing

Leadership

Regulatory knowledge

English

Ausbildung

Bachelor's degree

Advanced degree preferred

Tools

ISO 13485

GxP frameworks

EMA expectations

Jobbeschreibung

About This Role

As part of the Corporate Quality team, you will play a key role in Quality Audits, with a focus on internal and external audits, supplier and partner oversight, and inspection readiness. Based in Baar, Switzerland, the role has a broad scope across Europe and Rest of World regions.

About This Role

As part of the Corporate Quality team, you will play a key role in Quality Audits, with a focus on internal and external audits, supplier and partner oversight, and inspection readiness. Based in Baar, Switzerland, the role has a broad scope across Europe and Rest of World regions.

Depending on experience and level, you will independently plan, lead, and execute audits across GMP/GDP, ISO 13485 and global GxP regulatory frameworks, with a strong focus on regulatory expectations including EMA and country-specific health authority requirements.

At Principal level, you will take the lead on complex, high-risk audits, provide senior technical expertise, engage with site leadership and senior quality stakeholders, and coach other auditors.

At Senior Associate III level, you will independently lead audits and contribute to the execution of the regional audit program, building further expertise in complex and multi-country auditing.

Across both levels, you will contribute to strong quality governance, inspection readiness, effective remediation, and the continued development of auditing capabilities within the team.

We are primarily recruiting for a Principal Auditor, Quality Audits. However, we recognize that strong candidates may bring different levels of experience and expertise. Candidates who demonstrate strong auditing capabilities but do not fully meet the Principal-level requirements may also be considered for a Senior Associate III, Quality Audits opportunity within the team, with level and responsibilities determined based on experience and qualifications.

What You’ll Do

• Independently plan, lead, and execute complex, high-risk internal GMP/GDP and ISO 13485 audits across Europe and Rest of World.


• Lead and execute for-cause external audits of critical suppliers, contract manufacturers, and service providers.


• Apply advanced risk-based auditing methodologies incorporating regional regulatory nuances.


• Prepare inspection-ready audit reports.


• Review, challenge, and approve CAPA responses for complex findings, and monitor remediation progress.


• Serve as a senior technical resource and coach auditors during execution of complex audits.


• Support the Associate Director in executing the regional audit program, including audit schedule coordination.


• Provide expert input for regulatory interactions and inspection readiness.


• Mentor auditors and contribute to strengthening overall audit capability.


• Communicate critical findings and compliance gaps with senior-level context.


• Influence remediation strategies and monitor resolution of significant quality issues.

Who You Are

You are a highly skilled auditor with a passion for quality assurance and regulatory compliance. You possess the ability to think critically and navigate complex regulatory environments with ease. Your dedication to excellence drives you to execute audits with precision and integrity. You are a natural leader who thrives in collaborative settings, easily communicating complex audit findings and influencing remediation strategies. Your attention to detail and commitment to continuous improvement make you an invaluable resource to your team and the organization.

Required Skills For Principal Auditor, Quality Audits

• Bachelor of Science in Life Science, Engineering, or related technical discipline (advanced degree preferred).


• Minimum of 13+ years experience in a regulated pharmaceutical, biotechnology, or medical device environment.


• Minimum of 5+ years progressive auditing experience, including leadership of complex, multi-country audits.


• Demonstrated expertise in EMA expectations, ISO 13485, and global GxP frameworks.


• Fluent in English.

Preferred Skills - Principal Auditor, Quality Audits

• Advanced terminal degree (MD, PhD, PharmD).


• Experience in coaching and mentoring auditors.

Required Skills For Senior Associate III, Quality Audits

• Bachelor of Science in Life Science, Engineering, or related technical discipline.


• Minimum of 10+ years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.


• Minimum of 4+ years of auditing experience, including independent Lead Auditor responsibilities.


• Demonstrated experience with ISO 13485 and global GxP regulatory frameworks (FDA, EMA).


• Proficiency in English.

Preferred Skills - Senior Associate III, Quality Audits

• Advanced terminal degree (MD, PhD, PharmD).


• Fluency in additional languages.


• Experience with supplier qualification processes.

Job Level: Management

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.