Global Lead Auditor, Quality & Compliance

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

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.