• Qualification, monitoring, and management of critical business partners/service providers (e.g., TPIs) for FME D GmbH to ensure regulatory compliance of distribution channels to the end consumer based on valid processes and regulatory requirements within the respective area of responsibility
• QAA control (timely creation, completion, and maintenance based on centrally provided templates)
• Support with Initiation of mapping measures for the qualification and support of distributors, pharmaceutical wholesalers, and critical service providers
• Collaboration with the drafting, updating and maintaining quality assurance agreements with distributors, wholesalers and critical service providers in close cooperation with Q & R Hub
• Provide oversight over QAA status with TPIs/FME subsidiaries and respective reporting to relevant stakeholders
• Interface management for operational questions to the QAA with, for example, DGRA, Labelling Office, GTO, TPI Governance, Medical Device Vigilance and Trading Goods Department regarding their impact on TPI QAAs
• Preparation and support in internal and external surveillance audits
• Support with preparation of other service level or service agreements
• Implementation of quality assurance mapping measures
• Collaboration in international and cross-departmental project work

• After obtaining the appropriate auditor qualification, conducting audits of critical service providers (e.g., distributors, FME marketing & sales organizations within the framework of the quality management system or audits with a changed or extended scope, such as ISO 13485, GDP, etc.)
• The position holder will take on project tasks in the area of Regulatory Affairs & QMS International that are initiated to ensure compliance with external requirements as well as to support the identification, definition, implementation, monitoring, reporting, and follow-up of corporate processes and directives