Head of R&D Quality

Sanofi

Head of R&D Quality leading Sanofi’s centralized biopharma quality organization across research, clinical development, regulatory submission, and post-approval activities. Driving OneQuality transformation, compliance, risk management, and AI-enabled quality processes.

Posted 8/4/2026full-timeMorristown • Massachusetts, New Jersey • 🇺🇸 United StatesLead💰 $293,250 - $423,583 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in leading R&D Quality organizations, driving cultural transformation, and implementing quality strategies aligned with corporate objectives. Possesses deep knowledge of GxP regulations and the R&D lifecycle, with a strong focus on compliance and operational excellence.

Highest-signal resume keywords

15+ Years In Pharmaceutical R&D QualityGxP Regulations ExpertiseLeadership Of Large Quality OrganizationsExperience With FDA And EMA InspectionsData-Driven Quality Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management SystemsChange Control ManagementCAPA ManagementRisk Management FrameworksKPI MonitoringAudit And Inspection ManagementDocumentation ComplianceVendor OversightDigital TransformationAI-Enabled Quality Processes

Soft Skills

Strong Communication SkillsExceptional Executive PresencePeople Leadership SkillsAbility To Influence C-SuiteCollaboration In Matrixed Organizations

Industry Keywords

GCPGVPGLPGMPClinical QualityPharmacovigilance QualityRegulatory QualityIVDRReal-World EvidencePost-Approval Settings

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead the design, build-out, and operationalization of a centralized R&D Quality organization and unified R&D OneQuality operating model
Drive cultural and operational transformation toward a high-performance, collaborative, compliance-focused organization
Own quality accountability 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 oversight of Clinical, Pharmacovigilance, Medical, and Regulatory Quality teams
Build standardized transversal quality frameworks for documentation, training, vendor oversight, audits, inspections, metrics, change controls, data quality, and resource allocation
Partner with R&D leadership, the CMO office, and cross-functional stakeholders to align quality strategy with R&D priorities
Represent R&D Quality in senior governance forums, Works Councils, and regulatory agency interactions
Establish decision rights, governance structures, and escalation pathways
Implement integrated risk management frameworks and quality alert systems
Define and monitor KPIs for continuous improvement and operational excellence
Oversee deviation and CAPA management, change control, and risk management processes

Requirements

What you’ll need

15+ years of progressive experience in pharmaceutical R&D Quality
Strong track record in GxP-regulated environments, including GCP, GVP, GLP, and/or GMP
Experience leading large, complex quality organizations of 100+ FTEs across multiple functions or geographies
Experience designing and implementing new operating models, leading organizational transformation, driving change management, and building high-performing teams
Deep knowledge of the R&D lifecycle from early research through post-approval
Familiarity with clinical, pharmacovigilance, medical, and regulatory quality domains
Experience managing FDA, EMA, and other health authority inspections and representing quality in high-stakes regulatory interactions
Exceptional executive presence and ability to influence and engage at C-suite level
Strong people leadership skills for geographically distributed teams
Ability to balance quality governance with enabling business partnership
Ability to lead through ambiguity and align complex, matrixed organizations
Strong communication skills for translating complex quality and compliance topics to non-specialists
Comprehensive knowledge of GxP regulations and international regulatory frameworks
Familiarity with IVDR and evolving requirements for 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 using metrics, dashboards, and performance management frameworks

Benefits

Comp & perks

Opportunities for promotion or lateral career moves, at home or internationally
Rewards package recognizing contribution and impact
Health and wellbeing benefits
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Patient engagement in drug development
Work with cutting-edge AI, data, and digital platforms
Employee benefit programs