Executive Director, Research & Development Quality Assurance; RDQA

Overview

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 growing organization, working alongside exceptional colleagues and strategic partners worldwide, contributing to global health initiatives.

Moderna’s 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 area's renowned universities and research institutions.

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.

• 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.
• 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.

• We behave like owners. The solutions we’re building go beyond any job description.
• We digitize everywhere possible using the power of code to maximize our impact on patients.

• 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…