Senior GxP Auditor - External & Supplier Quality

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

This is a senior auditor role with responsibility for the planning, execution, and follow‑up of GxP audits across external manufacturing partners and suppliers.

The position is clearly focused on external and supplier quality oversight , rather than internal QA operations or people management. You will act as a lead auditor and subject‑matter expert , independently assessing compliance, identifying risk, and ensuring that audit outcomes are effectively managed within the quality system.

You will work closely with Quality, Procurement, and External Manufacturing teams, serving as a key interface between the organisation and its external partners in all audit‑related matters.

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