Senior GxP Auditor - External & Supplier Quality

Real; Bayern; Hybrid; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Real is looking for a Senior Auditor in Germany to oversee planning, execution, and follow-up of GxP audits for external manufacturing partners. The role requires several years of auditing experience in regulated industries and solid knowledge of GMP regulations. This position allows for work autonomy in a hybrid model, focusing on external quality governance. Candidates should possess excellent English communication skills, with German being an advantage.

Qualifikationen

• Several years of experience as a GxP / GMP Auditor in a regulated industry.
• Proven experience auditing CMOs, CDMOs, and external suppliers.
• Ability to work independently and make well-founded, risk-based quality decisions.

Aufgaben

• Planning and execution of GMP and GDP audits of suppliers.
• Preparation of structured audit reports and clear communication of findings.
• Documentation and management of audit activities within QMS.

Kenntnisse

GxP / GMP auditing

Knowledge of GMP and/or GDP regulations

Risk-based decision making

Clear communication for stakeholders

Very good English skills

Tools

QMS platforms (TrackWise)

Jobbeschreibung

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

SThree_Germany is acting as an Employment Agency in relation to this vacancy.