Belgium
Deutschland
France
日本
Nederland
Saudi Arabia
Schweiz
United Arab Emirates
United Kingdom
United States
Über diese Stelle
Wichtige Fakten
Senior GxP Auditor - External & Supplier Quality
Festanstellung
Ja
München, Bayern, Deutschland
€90000 - €100000 per annum €
Our client is an established life‑sciences organisation operating within a highly regulated GMP and GDP environment. The company collaborates with a broad network of CMOs, CDMOs, and critical suppliers across Europe and globally, supporting the manufacture and distribution of medicinal products where regulatory compliance, audit robustness, and quality governance are essential to patient safety.
External manufacturing and supplier activities are governed through mature quality systems, risk‑based oversight models, and established QMS platforms, ensuring alignment with European and international regulatory authorities.
About the Role
Key Responsibilities
- Planning and execution of GMP and GDP audits of CMOs, CDMOs, suppliers, and service providers
- Independent assessment of external partner compliance, quality systems, and regulatory risk
- Preparation of structured audit reports and clear communication of findings
- Review, evaluation, and follow‑up of CAPAs, deviations, and change controls arising from audits
- Ongoing oversight of supplier audit status and inspection readiness
- Consistent application of regulatory requirements and internal quality standards
- Documentation and management of audit activities within an enterprise QMS (e.g. TrackWise)
- Contribution to regulatory inspections and authority interactions related to external partners
Your Profile
- Several years of experience as a GxP / GMP Auditor in a regulated industry (pharmaceutical, biotech, or similar)
- Proven experience auditing CMOs, CDMOs, and external suppliers
- Solid knowledge of GMP and/or GDP regulations and audit methodologies
- Practical experience working with QMS platforms, ideally TrackWise or equivalent
- Ability to work independently and make well‑founded, risk‑based quality decisions
- Clear, professional communication style suitable for senior internal and external stakeholders
- Very good English skills; German is an advantage
Why This Role
- Senior, audit‑focused position with clear responsibility and autonomy
- Direct involvement in external manufacturing and supplier governance
- Hybrid working model with Munich as location base
- Long‑term perspective within a stable, regulated environment
- Role aligned with experienced auditors seeking technical depth rather than line management
SThree_Germany is acting as an Employment Agency in relation to this vacancy.
