Associate Director, Country Quality, Germany (m/w/d)

Job description

If you’re interested in this role, please apply in English and include an English version of your Resume/CV. The Role: Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build a career that makes a real difference for patients. Moderna is strengthening its presence in Munich, a key biotech hub in Germany. Our team leads commercial operations to bring our mRNA medicines to patients across the country. We welcome professionals ready to help shape the future of medicine. Moderna is seeking an experienced Quality leader to take ownership of Quality governance and regulatory compliance across our German commercial operations, ensuring the safe and compliant distribution of our innovative mRNA medicines and vaccines. Combining strategic Quality leadership with hands-on statutory accountability as Responsible Person (RP/RPi), you will oversee the local Quality Management System, safeguard product integrity and maintain compliance with German pharmaceutical legislation and EU Good Distribution Practice (GDP). Working at the intersection of commercial operations, global Quality functions and regulatory authorities, you will have the opportunity to shape a robust, inspection-ready Quality framework that supports patient safety, operational excellence and Moderna's continued growth in Germany. Here's What You'll Do: Lead Quality governance for Moderna Germany: Act as the primary Quality representative for Moderna's German commercial operations, ensuring that all vaccine and pharmaceutical activities are conducted in accordance with applicable Good Practices (GxP), company policies, Standard Operating Procedures (SOPs), marketing authorizations, contractual obligations, Quality Technical Agreements and Health Authority requirements. Serve as the Company's Management Representative and principal Quality contact for governmental authorities, supporting appropriate vaccine distribution within the German national healthcare system and resolving reported product quality issues. Own and continuously strengthen the local Quality Management System: Implement, maintain and continuously improve Moderna Germany's QMS, ensuring effective integration of German regulatory requirements into the enterprise Quality Management System. Develop, update and ensure consistent application of local SOPs, policies and work instructions, maintaining alignment with global Quality standards, commercial licensing requirements and the broader Quality organization. Fulfil statutory responsibilities as Responsible Person (RP/RPi): Personally undertake the responsibilities associated with Moderna Germany GmbH's Wholesale Distribution License in accordance with EU Guidelines 2013/C 343/01 and applicable German legislation, including § 52a (3) AMG. Ensure that authorized wholesale distribution activities are appropriately managed, Quality records remain accurate and complete, and all applicable national requirements are fulfilled. Maintain continuous 24-hour, seven-day contactability as required for the RP function. Oversee pharmaceutical distribution and supply chain Quality: Ensure that Moderna's distribution operations maintain the quality, integrity, security and appropriate storage conditions of medicinal products throughout the German supply chain. Oversee the implementation and ongoing monitoring of distribution systems, including contractual arrangements, technical specifications, transportation requirements and Quality oversight of pharmaceutical subcontractors. Manage third-party logistics and external Quality partnerships: Act as the principal Quality interface with third-party logistics providers, overseeing the receipt, storage, handling and distribution of goods within warehouse operations. Ensure that suppliers and customers are appropriately approved, that subcontracted activities potentially affecting GDP compliance receive the necessary authorization, and that transportation arrangements preserve product integrity and security. Maintain comprehensive oversight of inventory and product disposition: Monitor stock forecasts, distribution authorizations, transport conditions, product returns and potential or confirmed shortages, including required regulatory declarations. Oversee batch release and market distribution controls, coordinate batch recalls and ensure appropriate decisions regarding the final disposition of returned, rejected, recalled or suspected falsified products. Personally approve returns to saleable stock in accordance with applicable GDP requirements. Drive complaint management, deviation investigations and Quality risk mitigation: Oversee local product quality complaints, deviations, risk assessments and associated corrective and preventive actions (CAPAs). Ensure that customer complaints are investigated and resolved effectively, Quality risks are escalated appropriately, and robust corrective measures are implemented to prevent recurrence and protect patients. Lead inspection readiness, audit preparation and Quality performance monitoring: Prepare and coordinate internal and external audits, regulatory inspections, certifications and Quality reviews. Ensure that self-inspections are conducted at appropriate intervals against an established program, with effective follow-up and monitoring of CAPAs. Define, monitor and report Quality-related key performance indicators (KPIs), translating performance data into actionable improvements and maintaining a state of continuous inspection readiness. Ensure effective regulatory reporting and product safety escalation: Maintain appropriate engagement with German Health Authorities on Quality and distribution matters, including the reporting of medicinal products suspected of being falsified and the declaration of potential or confirmed supply shortages where required. Coordinate timely and effective medicinal product recalls, ensuring clear communication, accurate documentation and appropriate regulatory oversight. Maintain rigorous documentation, training and data integrity standards: Ensure compliance with Good Documentation Practices, data integrity principles and applicable GxP requirements. Maintain complete, accurate and inspection-ready Quality records, including documentation of delegated RP duties. Ensure that initial and continuous training programs are implemented and maintained, and personally complete all assigned training and periodic requalification requirements within prescribed timelines. Partner across Moderna's global and local Quality network: Collaborate closely with Global and Local Quality teams, Drug Substance (DS) and Drug Product (DP) Quality, commercial stakeholders and the General Manager for Germany and Switzerland. Provide Quality expertise across commercial and market oversight activities, including advertising, promotional compliance and relevant clinical activities. Translate global Quality strategy into practical local execution, ensuring alignment between enterprise requirements and German regulatory expectations. Drive operational excellence and continuous improvement: Support departmental budget planning, schedules and administrative activities associated with local Quality operations. Apply analytical thinking and risk-based decision-making to improve Quality processes, simplify workflows and strengthen cross-functional collaboration. Explore opportunities to leverage digital technologies, automation and Generative AI-enabled tools, where appropriately validated and compliant, to enhance Quality documentation, regulatory intelligence, performance monitoring and operational efficiency. Champion an inclusive, accountable and collaborative Quality culture: Operate as an influential individual contributor, providing expert Quality leadership without direct line-management responsibility. Build trusted relationships across a matrixed international organization, foster collaboration and continuous improvement,