Global R&D Quality Assurance Executive Leader

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

Benefits offered by this job

Healthcare coverage

Well-being resources

Family planning benefits

Generous PTO

Equity opportunities

Job summary

Moderna in Cambridge, Massachusetts, seeks an Executive Director, R&D Quality Assurance to lead global QA across GxP domains from research through late-stage development. You will set strategy, governance, and an operational excellence framework, partnering with Clinical Development, Pharmacovigilance, and Regulatory.

This role requires senior leadership, a data-driven quality culture, and a track record of successful inspections.

Qualifications

• 15+ years in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP.
• 10+ years leading multifunctional quality organizations within the R&D sector.
• Experience developing and managing budgets and resource allocation.
• Experience developing global audit programs and hosting health authority inspections.
• Knowledge of FDA, EMA, MHRA, PMDA, ICH regulations and EU PV guidance.

Responsibilities

• Provide enterprise governance of GCP, GVP, GLP, and GCLP across Moderna’s development portfolio.
• Define and execute a robust, forward-looking quality strategy aligned with regulatory requirements.
• Act as Quality business partner to R&D leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance.
• Embed risk-based quality management in study design, data generation, and vendor oversight.
• Serve as the Quality leader during global regulatory inspections and ensure timely resolution of findings.
• Build and lead a high-performing R&D QA team and promote a culture of continuous improvement.

Skills

GxP knowledge

Quality leadership

Regulatory inspections

Cross-functional leadership

Risk management

Strategic thinking

Data-driven culture

Education

Bachelor’s degree in life science

Advanced degree preferred

Job description

Moderna in Cambridge, Massachusetts, seeks an Executive Director, R&D Quality Assurance to lead global QA across GxP domains from research through late-stage development. You will set strategy, governance, and an operational excellence framework, partnering with Clinical Development, Pharmacovigilance, and Regulatory.

This role requires senior leadership, a data-driven quality culture, and a track record of successful inspections.