Moderna
Executive Director, Research & Development Quality Assurance (RDQA)
Moderna, Cambridge, Massachusetts, us, 02140
Executive Director, Research & Development Quality Assurance (RDQA)
Moderna is seeking an Executive Director of Research & Development Quality Assurance (RDQA) to lead and shape our global R&D quality strategy across all GxP domains. The role reports to the Head of Quality and will set the strategic direction, governance model, and operational excellence framework for QA within Research and Development.
Key Responsibilities
Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s entire development portfolio.
Define and execute a forward‑looking quality strategy aligned with global regulatory requirements and Moderna’s innovation agenda.
Act as the primary QA 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.
Basic Qualifications
Bachelor’s 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.
15+ years’ experience leading multifunctional quality organizations within the research and development sector.
Expertise in overseeing comprehensive resource and staffing management, building high‑performing teams, and fostering a culture of continuous improvement.
Experience in developing and executing robust audit schedules and coordinating cross‑functional efforts for regulatory compliance.
Demonstrated success in hosting global audit programs and health authority inspections with positive outcomes.
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH, and EU PV regulations, including ICH E2 and EU PV legislation.
Proven ability to collaborate and influence in a fast‑paced, matrixed environment with strong cross‑functional partnership skills.
Exceptional leadership and people‑development skills with a track record of building and inspiring 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 Salary range: $224,900.00 – $404,600.00. Additional compensation may include annually discretionary bonus, incentive compensation, or equity award based on company plan eligibility and performance.
Best‑in‑class healthcare coverage with voluntary benefit programs.
Holistic well‑being support: fitness, mindfulness, and mental health resources.
Family planning benefits, including fertility, adoption, and surrogacy support.
Generous paid time off, vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
Savings and investment opportunities.
Location‑specific perks.
About Moderna Founded in 2010, Moderna builds the leading mRNA technology platform to reimagine how medicines are created and delivered. Our mission is to change the world through science and innovation. New employees are invited to join our global team to advance groundbreaking work in mRNA medicines and improve global health outcomes.
Our Working Model Moderna champions a 70/30 work model: 70% in‑office—facilitating collaboration, innovation, teamwork, and mentorship.
Equal Opportunities Moderna is committed to equal employment opportunity for all applicants regardless of race, color, sex, gender identity, sexual orientation, disability, veteran status, or other protected characteristics. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations We offer reasonable accommodations to qualified applicants with disabilities. Contact the Accommodations team at
leavesandaccommodations@modernatx.com
for assistance.
Export Control Notice This position may involve access to export‑controlled technology. Employment is contingent on the applicant’s ability to comply with U.S. export control laws. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible; we do not sponsor non‑U.S. persons for an export control license.
Seniority Level Executive
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
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Key Responsibilities
Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s entire development portfolio.
Define and execute a forward‑looking quality strategy aligned with global regulatory requirements and Moderna’s innovation agenda.
Act as the primary QA 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.
Basic Qualifications
Bachelor’s 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.
15+ years’ experience leading multifunctional quality organizations within the research and development sector.
Expertise in overseeing comprehensive resource and staffing management, building high‑performing teams, and fostering a culture of continuous improvement.
Experience in developing and executing robust audit schedules and coordinating cross‑functional efforts for regulatory compliance.
Demonstrated success in hosting global audit programs and health authority inspections with positive outcomes.
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH, and EU PV regulations, including ICH E2 and EU PV legislation.
Proven ability to collaborate and influence in a fast‑paced, matrixed environment with strong cross‑functional partnership skills.
Exceptional leadership and people‑development skills with a track record of building and inspiring 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 Salary range: $224,900.00 – $404,600.00. Additional compensation may include annually discretionary bonus, incentive compensation, or equity award based on company plan eligibility and performance.
Best‑in‑class healthcare coverage with voluntary benefit programs.
Holistic well‑being support: fitness, mindfulness, and mental health resources.
Family planning benefits, including fertility, adoption, and surrogacy support.
Generous paid time off, vacation, volunteer days, sabbatical, global recharge days, and a discretionary year‑end shutdown.
Savings and investment opportunities.
Location‑specific perks.
About Moderna Founded in 2010, Moderna builds the leading mRNA technology platform to reimagine how medicines are created and delivered. Our mission is to change the world through science and innovation. New employees are invited to join our global team to advance groundbreaking work in mRNA medicines and improve global health outcomes.
Our Working Model Moderna champions a 70/30 work model: 70% in‑office—facilitating collaboration, innovation, teamwork, and mentorship.
Equal Opportunities Moderna is committed to equal employment opportunity for all applicants regardless of race, color, sex, gender identity, sexual orientation, disability, veteran status, or other protected characteristics. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations We offer reasonable accommodations to qualified applicants with disabilities. Contact the Accommodations team at
leavesandaccommodations@modernatx.com
for assistance.
Export Control Notice This position may involve access to export‑controlled technology. Employment is contingent on the applicant’s ability to comply with U.S. export control laws. Only U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible; we do not sponsor non‑U.S. persons for an export control license.
Seniority Level Executive
Employment Type Full‑time
Job Function Research, Analyst, and Information Technology
#J-18808-Ljbffr