Executive Director, Research & Development Quality Assurance; RDQA

Position: Executive Director, Research & Development Quality Assurance (RDQA)
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* 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.

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. In 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 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. 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.
** Here's

What You’ll Do:

**** Your key responsibilities will be:
*** 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.
** 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…