ABOUT THE ROLE

The Digital R&D – Delivery Excellence Lead operates as the Digital Risk Hub Ambassador serves as an operational enabler within Sanofi's Digital R&D Hub, empowering Software Engineering and Agile Product teams to own and embed compliance into their day-to-day activities. This role supports compliance enablement across the software lifecycle while enabling teams to produce compliant, high-quality deliverables through practical, engineer-friendly approaches, working in close partnership with Global Digital Risk Advisors.

JOB SUMMARY

The Delivery Excellence Lead operates as an operational enabler, working in active partnership with Global Digital Risk Advisors across Digital domains and coalitions:

• Compliance Enablement: Enable Digital R&D Hub teams to execute compliance activities aligned with Digital Risk and Compliance frameworks, fostering ownership rather than gatekeeping
• Agile Enablement: Embed compliance into agile ceremonies (backlog refinement, sprint reviews) and guide teams in creating compliant System Lifecycle deliverables
• SDLC/SLC Support: Provide hands-on support throughout the Software Development Life Cycle (SDLC) and Solution Life Cycle (SLC), promoting risk-based validation and "Compliance by Design" principles
• Partnership with Global Digital Risk Advisors: Work in continuous partnership with Global Digital Risk Advisors, ensuring local execution aligns with global risk strategies and compliance expectations
• Framework Alignment: Ensure all activities are anchored to the Global Digital Risk and Compliance framework

The role operates across risk domains encompassing GxP compliance as the primary focus, but also Data Privacy, Cybersecurity, and Artificial Intelligence as needed, all anchored to the Global Digital Risk and Compliance framework.

Out of Scope:

The following activities remain under Global Digital Risk & Compliance team ownership. The Ambassador may contribute in a supporting capacity under Global Digital Risk Advisors' leadership:

• Risk Profile Assessment
• Control/Compliance Strategy (incl. Validation Plans)
• GxP Authorization for Use Advisory
• Third-Party Audits
• GxP Periodic Reviews & Internal Controls Assessments
• Audit & Inspection Coordination

KEY RESPONSIBILITIES

All responsibilities are executed in active partnership with Global Digital Risk Advisors for their respective Digital domains and coalitions.

1. Stakeholder Partnership & Enablement

• Serve as point of contact for Digital R&D Hub Engineering and Service teams to address questions and support needs as Level 1 / Initial conversations.
• Work in continuous partnership with Global Digital Risk Advisors, ensuring alignment on priorities and compliance approaches.
• Enable teams to own compliance rather than acting as quality control gatekeeper.

2. Agile Compliance Enablement

3. SDLC/SLC (Ex: Computerized Systems Validation Support)

• Engage teams to understand solution roadmaps and operational priorities, providing practical guidance on risk management and action planning throughout the full SDLC/SLC
• Guide Software Engineering and Product teams in creating compliant System Lifecycle deliverables, supporting computerized system validation and required controls implementation.
• Promote risk-based validation and Computer System Assurance (CSA) approaches, embedding "Compliance by Design" principles from the earliest stages rather than post-facto corrections.
• Translate compliance requirements into practical, engineer-friendly approaches and embed compliance naturally into agile ceremonies (backlog refinement, sprint reviews)
• Coach teams on maintaining audit-ready practices with minimal overhead, supporting tooling adoption for documentation, traceability, and validation.
• Identify compliance risks and control gaps early in the development lifecycle; communicate/ escalate to Global Digital Risk Advisors as appropriate.

4. Compliance Assurance & Monitoring (Priority: High)

• Perform control monitoring and compliance health checks.
• Support adherence to regulatory requirements and Sanofi's Quality Standards through enablement.
• Provide compliance metrics, dashboards, and actionable insights.

5. Audit & Assurance Support (Priority: Medium)

• Enable teams to defend their System Lifecycle and Validation practices.
• Provide operational support during audit and assurance activities.
• Support post-audit action planning under Global Digital Risk Advisors' leadership.

6. Training & Education

• Deliver practical training sessions or on-the-job assistance to Digital R&D Hub teams.
• Educate teams on risk domains and risk control activities through engineer-friendly approaches.
• Coach teams on compliance practices and enable self-sufficiency.
• Participate in risk domain communities of practice.
• Support knowledge-sharing between local teams and Global Digital Risk Advisors.

7. Continuous Improvement

• Provide input/ suggestions for improvements in the global Digital risk and compliance framework and QMS.
• Identify opportunities to enable self-service capabilities and optimize SDLC/SLC processes.
• Share feedback from Digital R&D Hub teams to support continuous improvement of policies and frameworks.

Required Qualifications & Experience

• 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 Sciencs/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.

Pursue progress, discover extraordinary

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