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

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, and promote a culture in which regulatory compliance, patient safety, innovation and personal accountability are embedded in everyday decisions.
• Maintain oversight of additional regulated activities: Ensure that any applicable medical sample monitoring requirements are fulfilled, that product-specific obligations imposed by German law are respected, and that the Quality organization maintains comprehensive knowledge of local regulatory requirements alongside a strong understanding of Moderna's global Quality functions.

The key Moderna Mindsets you’ll need to succeed in the role:

• “We behave like owners. The solutions we’re building go beyond any job description.”
• "We act with dynamic range, driving strategy and execution at the same time at every step.”

 

Here’s What You’ll Bring to the Table:

• Masters degree or comparable in a health related field or life science
• The RP should meet the qualifications and all conditions provided for by German legislation as outlined in § 52a (3) AMG
• A degree in pharmacy is desirable. The RP should have appropriate competence and experience as well as knowledge of and training in GDP.
• Strong managerial skills across countries and ability to partner closely and effectively cross-functionally
• Experience and confidence in working with all levels of management and consulting with key business stakeholders, including an ability to influence for greater outcomes
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in an effective way and to orchestrate plans to resolve issues and mitigate risks while working in a matrixed environment.
• Ability to manage multiple projects simultaneously in a fast-paced environment
• Excellent German & English language skills.

 

Our Working Model 

As we build our company, we have always believed an in-person culture is critical to our success.

Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs
• A holistic approach to well-being with access to fitness, mindfulness, and mental health support
• Family building benefits, including fertility, adoption, and surrogacy support
• Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investments to help you plan for the future
• Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. 

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. 

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. 

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply! 

Moderna is committed to equal opportunity in employment and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. 

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. 

Moderna is committed to offering reasonable accommodation or adjustments to qualified job applicants with disabilities. Any applicant requiring an accommodation or adjustment in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations and Adjustments team at leavesandaccommodations@modernatx.com. 

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