Digital R&D - Delivery Excellence Expert

Responsibilities

• Act as a Digital Risk Hub Ambassador, empowering engineering and agile teams to embed compliance into their daily activities.
• Provide hands-on support throughout the Software Development Life Cycle (SDLC) and Solution Life Cycle (SLC) using risk-based validation and "Compliance by Design" principles.
• Guide teams in creating compliant System Lifecycle deliverables and implementing required controls.
• Embed compliance requirements into agile ceremonies such as backlog refinement and sprint reviews.
• Perform control monitoring, compliance health checks, and provide actionable compliance metrics and dashboards.
• Deliver practical training and coaching to Digital R&D Hub teams to enable self-sufficiency in risk management.
• 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.
• 7 to 10 years of experience in IT Quality and Compliance, CSV, or Service Assurance within the Life Sciences or BioPharma industry.
• Proven experience with Computer System Validation (CSV) for GxP systems, particularly 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.
• Ability to work effectively with complex, international, and multidisciplinary teams.

Preferred Qualifications

• Exposure to Cloud/SaaS validation and modern engineering practices.
• Experience with Computer System Assurance (CSA) approaches.

About the Company

Sanofi is a global healthcare leader dedicated to chasing the miracles of science to improve people's lives. We invest in our people to help them reach further and build smarter solutions that reach communities worldwide. At Sanofi, we foster a culture of diversity, inclusion, and continuous growth, empowering our employees to push boundaries and challenge convention.