Executive Director, R&D Quality Assurance & Strategy

BioSpace; Cambridge (MA); On-site; USD 225,000 - 405,000; Full time

Benefits offered by this job

Best-in-class healthcare coverage

Well-being resources

Generous paid time off

Job summary

Moderna in Cambridge, MA seeks an Executive Director, RDQA, to shape and drive the global R&D quality strategy across GxP domains. This senior leader partners with Clinical, Non-Clinical, and PV to ensure compliance, scientific integrity, and patient safety across the development lifecycle.

The role will host global inspections, lead a dispersed QA team, and push for a data-driven culture with risk-based quality management. Competitive US salary and benefits provided.

Qualifications

• Bachelor’s degree in life science or related field; advanced degree preferred.
• 15+ years in biopharma with deep GCP/GLP/GCLP/GVP expertise and clinical trial/regulatory experience.
• 10+ years leading multifunctional QA teams in R&D with budgets and staffing oversight.
• Experience hosting global health authority inspections (FDA/EMA/MHRA, etc.)

Responsibilities

• Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna’s development portfolio.
• Define and execute a forward-looking quality strategy aligned with global regulatory requirements.
• Act as the primary Quality partner to R&D leaders across Clinical, Non-Clinical, Research, and PV.
• Embed risk-based quality management in study design, data generation, and vendor oversight.
• Serve as Quality leader during global regulatory inspections, ensuring timely resolution of findings.
• Drive modernization of vendor oversight and external partnership performance.
• Build and lead a high-performing R&D QA team rooted in scientific credibility.
• Promote real-time quality management and early issue detection across R&D.
• Establish quality metrics and leading indicators for meaningful risk mitigation.
• Own end-to-end quality lifecycle for deviations, CAPAs, and inspection readiness.
• Oversee Pharmacovigilance Quality System (GVP) and safety database validation.
• Collaborate to maintain a fit-for-purpose R&D QMS supporting innovation.
• Monitor regulatory intelligence and update internal systems accordingly.

Skills

GCP/GVP/GLP/GCLP expertise

QA leadership in Biopharma

Regulatory inspections (FDA/EMA/MHRA)

Quality strategy development

Budget & resource management

Cross-functional collaboration

Audit program development

Data-driven quality culture

Education

Bachelor’s degree in life science or related field

Job description

Moderna in Cambridge, MA seeks an Executive Director, RDQA, to shape and drive the global R&D quality strategy across GxP domains. This senior leader partners with Clinical, Non-Clinical, and PV to ensure compliance, scientific integrity, and patient safety across the development lifecycle.

The role will host global inspections, lead a dispersed QA team, and push for a data-driven culture with risk-based quality management. Competitive US salary and benefits provided.