Key Responsibilities
* Maintain full compliance with Good Distribution Practice (GDP) under §52a AMG
* Act as the Responsible Person for all licensed activities involving the distribution of medicinal products in Germany
* Oversee operational quality standards related to storage, transport, and supply chain partners
* Conduct internal audits and manage external vendor qualification
* Lead deviation, CAPA, and change control processes
* Support Quality Management System (QMS) improvement initiatives
* Partner cross-functionally with Supply Chain, Quality Assurance, and Regulatory to ensure compliant product flow to market
Requirements
* Recognised qualification enabling appointment as Responsible Person under GDP guidelines (§52a AMG)
* Strong understanding of German and EU GDP regulations
* Previous experience in a distribution, pharmaceutical, or wholesaling environment
* Hands-on Quality Assurance knowledge — ideally with QMS ownership
* Fluent German language skills (written and spoken), English advantageous
* Proactive mindset with strong communication and decision-making capability