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Moderna · 2 weeks ago

Executive Director, Research & Development Quality Assurance (RDQA)

Bethesda, Maryland

Full-time

Onsite

Director/Executive

$225K/yr - $405K/yr

18+ years exp

Moderna is a pioneering company revolutionizing medicine through mRNA technology, seeking an Executive Director for Research & Development Quality Assurance. This leadership role involves shaping and driving Moderna’s global R&D Quality strategy across all GxP domains, ensuring regulatory compliance, scientific integrity, and patient safety throughout the R&D lifecycle.

BiotechnologyGeneticsHealth CareMedicalPharmaceuticalTherapeutics

Comp. & Benefits

No H1B

U.S. Citizen Only

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

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

Qualification

GCPGLPGCLPGVPQuality ManagementRegulatory ComplianceAudit ProgramsLeadershipAnalytical SkillsCollaborationStrategic ThinkingCommunication Skills

Required

Bachelor's degree in a life science or related field

18+ years of progressive Quality 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

15+ 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