Head of R&D Quality

Job title: Head of R&D Quality

• Location: Morristown, NJ

About the Job

Sanofi is seeking an experienced and forward-thinking quality leader to shape and lead the evolution of the R&D Quality organization. As Head of R&D Quality, you will report directly to the Chief Medical Officer (CMO), with accountability for quality across the full R&D lifecycle from early research through regulatory submission and post-approval activities. You will lead integrated functional and transversal quality capabilities, across R&D, Regulatory Affairs, Pharmacovigilance, and Medical to ensure quality is embedded throughout the product lifecycle and directly supports our mission to improve patient access and outcomes.

Reports to: Chief Medical Officer (CMO)

Team Size: ~180 people | ~9 Direct Reports

Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions.

About Sanofi

We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system — and innovative pipeline — enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.

Main Responsibilities

Organizational Leadership & Transformation

• Lead the design, build-out, and operationalization of a centralized R&D Quality organization, establishing a unified R&D OneQuality operating model

• Drive cultural and operational transformation to build a high-performance, collaborative, compliance-focused organization

• Serve as the single accountable leader for quality across the full R&D lifecycle from early research through regulatory submission and post-approval activities

• Develop and execute the enterprise quality strategy aligned with corporate objectives

• Drive digital transformation and AI-enabled quality processes

Functional Quality Oversight

Provide strategic direction and oversight to dedicated functional quality teams including:

• Clinical Quality: GCP compliance, clinical trial quality oversight

• Pharmacovigilance (PV) Quality: GVP compliance, safety data quality

• Medical Quality: RWE, PASS studies, Post Trial Access, IVDR compliance

• Regulatory Quality: Regulatory submission quality and compliance

• Ensure deep GxP expertise is maintained within each functional domain while enabling cross-functional collaboration and business partnering

Transversal Quality Capabilities

Build and lead standardized, scalable transversal quality frameworks including:

• Quality Documentation & Training Compliance: Harmonized documentation standards and training frameworks across R&D

• Vendor Quality Oversight: End-to-end vendor qualification, monitoring, and performance management

• Audits & Inspection Management: Coordinated audit planning, inspection readiness, and regulatory agency interaction

• R&D Quality Transversal Operations: Performance metrics, cross-functional change controls, data quality, and dynamic resource allocation

• Drive standardization of processes, tools, and ways of working to eliminate duplication and variability across R&D functions

Strategic Partnership & Governance

• Act as the OneQuality voice for R&D; a trusted, embedded strategic business partner enabling innovation through quality excellence

• Partner closely with R&D leadership, the CMO office, and cross-functional stakeholders (Regulatory, Clinical, Medical, M&S) to align quality strategy with R&D priorities

• Represent R&D Quality in senior governance forums, Works Councils, and regulatory agency interactions

• Establish clear decision rights, governance structures, and escalation pathways across the new organization

Risk, Compliance & Performance

• Ensure comprehensive, proactive quality coverage across all R&D deliverables, including but not limited to RWE & PASS studies, Post Trial Access, Research activities, and IVDR compliance

• Implement integrated risk management frameworks and quality alert systems to identify and mitigate compliance risks early

• Define and monitor KPIs to drive continuous improvement and operational excellence

• Oversee deviation & CAPA manag