Executive Director, Research & Development Quality Assurance (RDQA)

The Role:

Joining Moderna offers the unique opportunity to be part of a pioneering team thats revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases.

As an employee youll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide contributing to global health initiatives.

Modernas commitment to advancing the technological frontier of mRNA medicines ensures a challenging and rewarding career experience with the potential to make a significant impact on patients lives worldwide.

Moderna is solidifying its presence in Cambridge Massachusetts. Our head office here is more than just a global administrative center; it is a vital part of our efforts in pioneering mRNA technology and engaging in meaningful collaboration with the areas renowned universities and research Cambridge we aim to harness the wealth of knowledge and innovative spirit this region offers to further our global mission in medicine and healthcare. We are actively seeking talented individuals who are motivated by innovation and committed to making a significant impact. Join us at our Cambridge location where your contributions will be pivotal in advancing our groundbreaking work in mRNA medicines and improving global health outcomes.

This is a critical leadership opportunity for a seasoned Quality executive to shape and drive Modernas global R&D Quality strategy across all GxP domains. The Executive Director (ED) R&D Quality Assurance (RDQA) reporting to the Head of Quality will set the strategic direction governance model and operational excellence framework for Quality within Research and Development. The ED will serve as Modernas most senior QA leader across GCP GLP GCLP and GVP embedding proactive quality principles into the full R&D lifecycle from research through to late-stage development. This role partners closely with Clinical Development Pharmacovigilance Non-Clinical Development & Toxicology and Research ensuring end-to-end regulatory compliance scientific integrity and patient safety. With a strong emphasis on leadership innovation and transformation this position is accountable for cultivating a data-driven quality culture hosting global regulatory inspections and leading a high-performing QA team based in Cambridge.

Heres What Youll Do:

Your key responsibilities will be:

• Provide enterprise governance and oversight of GCP GVP GLP and GCLP compliance across Modernas entire development portfolio.

• Define and execute a robust forward-looking quality strategy in alignment with global regulatory requirements and Modernas innovation agenda.

• Act as the primary Quality business partner to R&D functional leaders across Clinical Non-Clinical Research and Pharmacovigilance areas.

• Embed risk-based quality management principles into study design data generation and vendor oversight practices.

• Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA EMA MHRA) ensuring timely and effective resolution of findings.

• Drive modernization of vendor oversight and shared accountability models elevating external partnership performance.

Your responsibilities will also include:

• Build and lead a high-performing solutions-oriented R&D QA team rooted in scientific credibility and operational excellence.

• Enhance Quality Culture across R&D by promoting real-time quality management early issue detection and continuous feedback loops.

• Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance.

• Own the end-to-end quality lifecycle for deviations CAPAs issue management regulatory intelligence and inspection readiness.

• Oversee the Pharmacovigilance Quality System (GVP) including signal management safety database validation and global safety inspection preparation.

• Collaborate with Global Systems & Compliance to maintain a fit-for-purpose R&D Quality Management System (QMS) that supports innovation and agility.

• Monitor global regulatory intelligence and evolving external expectations ensuring internal systems are updated accordingly.

The key Moderna Mindsets youll need to succeed in the role:

• We behave like owners. The solutions were building go beyond any job description.
  In this executive role you will serve as the quality conscience of Modernas entire R&D pipeline with ownership of not just systems and metrics but the culture strategy and mindset needed to make quality a competitive advantage.

• We digitize everywhere possible using the power of code to maximize our impact on patients.
  This role has a unique opportunity to modernize quality oversight by leveraging digital tools automation and data-driven insights from vendor performance analytics to proactive issue detection in the clinical and non-clinical space.

Heres What Youll Need (Basic Qualifications)

• Bachelors degree in a life science or related field; advanced degree preferred.

• 18 years of progressive Quality experience in the biopharmaceutical industry with deep expertise in GCP GLP GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials regulatory submissions laboratories and PV and clinical safety.

• 15 years experience leading multifunctional quality organizations within the research and development sector with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals.

• Expertise to oversee comprehensive resource and staffing management building high-performing teams and fostering a culture of continuous improvement and accountability.

• Experience in the development and execution of robust audit schedules coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration.

• Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes. Extensive knowledge of FDA EMA MHRA PMDA ICH and EU PV regulations/guidelines including ICH E2 and EU PV legislation.

• Extensive knowledge of FDA EMA MHRA PMDA ICH regulations guidance and local legislation for clinical trials including a ICH E6 (R3).

• Proven ability to collaborate and influence in a fast-paced matrixed environment; strong cross-functional partnership skills with Clinical Non-Clinical PV Regulatory and Digital groups.

• Exceptional leadership and people-development skills with demonstrated ability to build and inspire high-performing geographically dispersed teams.

• Excellent strategic thinking risk-based decision-making analytical and communication skills

• Agile and growth mindset; thrives in rapid growth and embraces continuous improvement and innovation.

Pay & Benefits

At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global well-being resources are designed to support youat work at home and everywhere in between.

• Best-in-class healthcare coverage 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 planning benefits including fertility adoption and surrogacy support

• Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary year-end shutdown

• Savings and investment opportunities to help you plan for the future

• Location-specific perks and extras

The successful candidate may be eligible for an annual discretionary bonus other incentive compensation or equity award subject to company plan eligibility criteria and individual performance.

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 to learn more about our current opportunities.

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.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a persons 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 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.

Accommodations

Were 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 accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation 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 team at .

Export Control Notice

This position may involve access to technology or data that is subject to U.S. export control laws including the Export Administration Regulations (EAR). As such employment is contingent upon the applicants ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements only individuals who qualify as U.S. persons (citizens permanent residents asylees or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.

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