Global Quality Audits Specialist II

Biogen; Baar; Sur place; CHF 120 000 - 150 000; Plein temps

Résumé du poste

Biogen is seeking a Senior Associate II in Quality Audits to support internal GMP/GDP and ISO 13485 audits across Europe and ROW, partnering with vendors, contract manufacturers, and service providers to ensure GxP compliance. The role emphasizes documentation, CAPA tracking, and inspection readiness under guidance from a Lead Auditor.

You will collaborate with site SMEs and Quality teams to gather records, assess supplier audits, and communicate findings effectively, strengthening our global

Qualifications

• Minimum 7 years of regulated pharma/biotech/medical device experience.
• Minimum 3 years progressive auditing experience, including leadership of multi-country audits.
• Demonstrated EMA, ISO 13485, and global GxP knowledge.

Responsabilités

• 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.
• 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.

Connaissances

Auditing

GxP compliance

Quality assurance

English proficiency

Cross-functional collaboration

Formation

Bachelor of Science in Life Science/Engineering

Advanced degree preferred

Description du poste

Biogen is seeking a Senior Associate II in Quality Audits to support internal GMP/GDP and ISO 13485 audits across Europe and ROW, partnering with vendors, contract manufacturers, and service providers to ensure GxP compliance. The role emphasizes documentation, CAPA tracking, and inspection readiness under guidance from a Lead Auditor.

You will collaborate with site SMEs and Quality teams to gather records, assess supplier audits, and communicate findings effectively, strengthening our global