Role Overview:
The German Affiliate Quality Director leads the establishment and management of the affiliate Quality Management System (QMS), ensuring compliance with German and EU Good Distribution Practice (GDP) standards and global quality requirements. This role serves as the Responsible Person for wholesale distribution authorization, providing independent quality oversight without line management responsibilities.
Key Responsibilities
- Drive Quality activities for affiliate setup, including establishing QMS, procedures, training, and supply chain controls before commercial launch.
- Provide Quality guidance to affiliate leadership and elevate compliance risks.
- Fulfill Responsible Person duties under German legislation and EU GDP guidelines, acting as the primary contact for regulatory inspections.
- Manage deviations, CAPAs, change controls, and oversee GDP-relevant service providers.
- Ensure effective handling of distribution activities, product complaints, recalls, and traceability.
- Approve outsourced activities, suppliers, and logistics providers, maintaining documented quality agreements.
Qualifications & Skills
- Degree in pharmacy, pharmaceutical sciences, or related field.
- 10+ years of progressive pharmaceutical Quality experience, including GDP within the German/EU supply chain.
- Strong knowledge of EU GDP requirements and German pharmaceutical legislation.
- Experience overseeing distribution, logistics, and temperature-controlled operations.
- Proficiency in German and English, both written and spoken.
- Authorized as Responsible Person in Germany preferred.
Reporting & Location
Reports to the Senior Director, Quality Global Affiliates, working closely with the German General Manager, based in Munich, with travel as needed.
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