Executive Director, Research & Development Quality Assurance (RDQA)

About the role

Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology, with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

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.

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 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

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.

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs.
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.