Executive Director, Research & Development Quality Assurance (RDQA)

The Role

This is a critical leadership opportunity for a seasoned Quality executive to shape and drive Moderna’s 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 Moderna’s 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.

Responsibilities

• Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s entire development portfolio.


• Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna’s 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.

Additional Responsibilities

• 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.

Qualifications

• Bachelor’s degree in a life science or related field; advanced degree preferred.


• 15+ years of progressive 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.


• 10+ 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 an 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

• 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 salary range for this role is $224,900.00 - $404,600.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. 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.

Equal Opportunity Employment

Moderna is committed to equal employment opportunity 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. 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 an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities.

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