Digital R&D - Delivery Excellence Specialist

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 product 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 insights through metrics and dashboards.
• Partner with Global Digital Risk Advisors to ensure local execution aligns with global risk strategies and GxP frameworks.
• Deliver practical training and coaching to teams to promote self-sufficiency and audit-ready practices.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or a related field.
• 4 to 7 years of experience in IT Quality and Compliance, Computer System Validation (CSV), or Service Assurance within the Life Sciences/BioPharma industry.
• Proven expertise in 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 Life Cycle (SDLC) in regulated environments.
• Experience working within Agile and DevOps environments.

Preferred Qualifications

• Exposure to Cloud/SaaS validation and modern engineering practices.
• Experience 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 our people to help them reach further and build smarter solutions that push the boundaries of medicine.