Head of R&D Quality

About the Role

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.

Key Responsibilities

• 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
• 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), and 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
• Build and lead standardized, scalable transversal quality frameworks including Quality Documentation & Training Compliance, Vendor Quality Oversight, Audits & Inspection Management, and R&D Quality Transversal Operations
• Drive standardization of processes, tools, and ways of working to eliminate duplication and variability across R&D functions
• 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
• 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 management, change control, and risk management processes across R&D

Experience & Background

• 15+ years of progressive experience in pharmaceutical R&D Quality, with a strong track record in GxP-regulated environments (GCP, GVP, GLP, and/or GMP)
• Demonstrated experience leading large, complex quality organizations (100+ FTEs) across multiple functions or geographies
• Proven track record in organizational transformation; designing and implementing new operating models, driving change management, and building high-performing teams
• Deep knowledge of the R&D lifecycle from early research through post-approval, with familiarity across clinical, pharmacovigilance, medical, and regulatory quality domains
• Experience managing regulatory agency inspections (FDA, EMA, and other health authorities) and representing quality in high-stakes regulatory interactions

Leadership & Interpersonal Skills

• Exceptional executive presence with the ability to influence and engage at C-suite level
• Strong people leadership skills; able to inspire, develop, and retain diverse, geographically distributed teams
• Collaborative and strategic mindset; able to balance the role of quality guardian with that of an enabling business partner
• Demonstrated ability to lead through ambiguity and drive alignment across complex, matrixed organizations
• Strong communication skills, with the ability to translate complex quality and compliance topics for non-specialist audiences

Technical Competencies

• Comprehensive knowledge of GxP regulations (GCP, GVP, GLP/GcLP) and international regulatory frameworks
• Familiarity with IVDR and evolving regulatory requirements in real-world evidence and post-approval settings
• Experience with quality management systems, audit and inspection management, vendor oversight, and documentation/training compliance
• Data-driven approach to quality, comfortable with metrics, dashboards, and performance management frameworks

Benefits & Perks

• A thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
• A wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
• At least 14 weeks' gender-neutral parental leave
• Opportunities to grow your talent and drive your career, whether through a promotion or lateral move, at home or internationally
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs

Reports to: Chief Medical Officer (CMO)
Team Size: ~180 people | ~9 Direct Reports