Digital R&D - Delivery Excellence Lead
On-site · Hyderabad, Telangana, India
Job Summary
Delivery Excellence Lead for Digital R&D operates as a hands-on enablement role partnering with Global Digital Risk Advisors to embed compliance into Agile and SDLC/SLC practices. Core focus areas include Compliance Enablement, Agile Compliance, SDLC/SLC support (including Computerized System Validation), audit/support during assurance activities, training, and continuous improvement of the Global Digital Risk & Compliance framework. The role covers GxP compliance as primary, with data privacy, cybersecurity, and AI considerations as needed, and requires partnering with cross-functional teams to promote risk-based validation, audit-ready practices, and engineer-friendly compliance outcomes. Requirements include a Bachelor's degree and 10–14 years of experience in IT Quality/Compliance or CSV within regulated Life Sciences/Biopharma environments, strong knowledge of 21 CFR Part 11, EU Annex 11, ALCOA, GAMP 5, and experience in Agile/DevOps in regulated settings, plus leadership capabilities across international teams. At Sanofi, we emphasize equal opportunities and a mission-driven culture.
Required Qualifications
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field
- 10 to 14 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
- Ability to engage with global and culturally diverse teams
- Ability to manage a team of Delivery Excellence Specialists and Experts
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