Digital R&D - Delivery Excellence Specialist
On-site · Hyderabad, Telangana, India
Job Summary
Digital R&D – Delivery Excellence Specialist operates as an operational enabler within Sanofi's Digital R&D Hub, partnering with Global Digital Risk Advisors to embed compliance into software lifecycle activities. Responsibilities include enabling teams to own compliance, embedding compliance into agile ceremonies, providing SDLC/SLC support and risk-based validation, maintaining audit-ready practices, delivering training, monitoring compliance, and contributing to continuous framework improvements. The role spans GxP compliance as a primary focus with data privacy, cybersecurity, and AI considerations, and requires collaboration across global, multidisciplinary teams to align with global risk strategies.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
- 4 to 7 years of experience, preferably within IT Quality and Compliance, CSV, Service Assurance within Life Sciences/Bio Pharma
- Proven experience with Computer System Validation (CSV) for GxP systems, especially R&D systems
- Strong understanding of FDA 21 CFR Part 11, EU Annex 11, Data Integrity Principles (ALCOA ++) and GAMP 5 guidelines
- Strong understanding of Software Development & IT Service Management activities within a regulated environment
- Experience in Agile/DevOps environments within regulated systems
- Exposure to Cloud/SaaS validation and modern engineering practices
- Extensive track record of successful cross-functional work with complex international and multidisciplinary teams
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