Head of Department

• 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

Head of R&D Quality leading biopharma quality strategy and transformation at Sanofi

Head of R&D Quality

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.

• Author and revise the Investigator Brochure (IB), synthesizing data with a focus on RLT aspects.
• Create and oversee Statistical Analysis Plans (SAPs) for clinical trials.
• Lead the writing of Clinical Study Reports (CSRs), integrating trial results and safety narratives.
• Compile and author summaries of nonclinical data for regulatory documents.
• Design and produce scientific figures and visuals for reports and presentations.
• Analyze clinical trial data to inform decisions and support team collaboration.
• Guide clinical scientists on best practices for document writing and workflows.

Head of Clinical Affairs leading clinical data for RLT portfolio

Head of Clinical Affairs

Head of Clinical Affairs overseeing clinical data generation and writing for RLT portfolio. Collaborating with teams to ensure compliance and strategic decision-making.

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Head of R&D Quality

Head of Clinical Affairs