Digital R&D - Delivery Excellence Lead

Responsibilities

• Act as a Digital Risk Hub Ambassador, empowering engineering and agile teams to embed compliance and risk management into the software development lifecycle.
• Provide hands-on support throughout the SDLC and SLC, promoting risk-based validation and "Compliance by Design" principles.
• Guide Software Engineering and Product teams in creating compliant System Lifecycle deliverables and implementing required controls.
• Embed compliance into agile ceremonies, such as backlog refinement and sprint reviews, using practical, engineer-friendly approaches.
• Perform control monitoring and compliance health checks to ensure adherence to regulatory requirements and Sanofi's Quality Standards.
• Deliver practical training and coaching to Digital R&D Hub teams to enable self-sufficiency in risk domains.
• Partner closely with Global Digital Risk Advisors to ensure local execution aligns with global risk strategies.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field.
• 10 to 14 years of experience in IT Quality and Compliance, preferably within the Life Sciences or BioPharma industry.
• Proven experience with Computer System Validation (CSV) for GxP systems, specifically R&D systems.
• Strong knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.
• Deep understanding of Data Integrity Principles (ALCOA++) and Software Development/IT Service Management in regulated environments.
• Experience working within Agile and DevOps environments.
• Exposure to Cloud/SaaS validation and modern engineering practices.
• Ability to manage a team of Delivery Excellence Specialists and Experts.
• Strong track record of working with complex, international, and multidisciplinary teams.

About the Company

Sanofi is a global healthcare leader dedicated to chasing the miracles of science to improve people's lives. We invest in transformative growth and cutting-edge digital innovation to accelerate the journey from discovery to therapy. At Sanofi, you will join a culture that values diversity, continuous learning, and the courage to challenge convention.