Senior Audit & Supplier Qualification Manager (Pharmacy)

About the role

We are looking for a highly qualified Senior Manager to lead audit planning and supplier qualification activities for our European headquarters in Munich. The role combines pharmaceutical expertise with strong audit and risk‑management skills to ensure compliance across our contract manufacturing organizations and suppliers.

Key responsibilities

• Plan, execute and report GMP/GDP audits at CMOs and suppliers.
• Manage follow‑up communication, CAPA implementation and audit documentation.
• Identify risks in day‑to‑day operations and support internal QA functions.
• Develop and negotiate Quality Agreements with internal stakeholders, CMOs and suppliers.
• Conduct integrated risk‑management activities, including re‑classification, score‑carding and metrics reporting.
• Support due‑diligence activities for new suppliers and acquisitions.

Required profile

• Degree in Pharmacy, Biology, Chemistry or a related scientific discipline (diploma, master’s or higher).
• 5‑8 years of GMP experience in a pharmaceutical company.
• Extensive knowledge of international guidelines (EudraLex Vol. 4, CFR 201/211, GAMP, ISO 19011).
• Proven auditor experience, preferably as Lead Auditor; auditor certification (CQI/IRCA, ASQ) is a plus.
• Strong assertiveness, independent working style and excellent English communication skills.
• Willingness to travel frequently.

Required skills

• GMP/GDP audit methodology.
• TrackWise Digital or comparable QMS IT system.
• Quality Agreement negotiation.
• Risk evaluation and management.

What we offer

• Competitive benefits package.
• Work‑life balance initiatives.
• Opportunities for growth and professional development.
• Health and wellbeing support.