Digital Risk & Compliance Lead – Controls Assurance

Job title: Digital Risk & Compliance Lead – Controls Assurance

• Location: Hyderabad – RMZ spire

About the job

We are the Digital Risk & Compliance team. Our mission is to drive Digital Risk & Compliance to protect patient safety and Sanofi growth. One of our key drivers is to foster the Digital risk culture through the management of risks linked to our Digital third-party solutions and service providers. 

We aim to provide Digital teams with timely, comprehensive third-party risk assessment and monitoring program in order to enable effective third-party selection decision making, maintain a high quality of services, and to ensure regulatory inspection readiness. To support this journey, we are looking for a “Digital Risk & Compliance Lead -Control Assurance”.  This person will be responsible for driving risk & compliance assurance across the Digital solutions and services third parties portfolio. He/She will particularly be focused on hands-on planning and management of third-party quality assessments, service provider quality, and quality agreements.  

Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Digital Risk & Compliance Lead within our Digital Risk & Compliance team, you’ll be instrumental to identify opportunities to integrate risk management strategies across risk domains and manage continuously evolving Pharma regulations, Cyber and Data Privacy risks into our third-party risk management program.  

Main responsibilities: -

• Third Party Assessments: Collaborate on the development of a comprehensive risk-based assessment (including audit) program in collaboration with risk partners (Cyber Security, Data Privacy) to create a truly cross risk domain auditing approach.

• Plan, organize, and conduct third party quality assessments and audits (typically remotely), Identify risks and areas of improvement and evaluate the adequacy of designed controls, drawing conclusions and presenting findings to Digital leadership teams.

• Manage, track and report corrective actions implemented by the third party to effectively address identified issues. Lead the execution of quality agreements with third parties based using a risk-based approach. Participate in the development and maintenance of a Digital third-party database to track and maintain qualification status.

• Third Party Quality Management: Provide quality and compliance oversight for outsourced help-desk service provider.

• Lead the strategic planning and execution of I.T quality agreements with third parties; extend, simplify, and harmonize practices across global Sanofi teams. Support transformation initiatives to implement third-party monitoring and automation initiatives.

• Execution Periodic Reviews Execute Periodic Reviews of GxP regulated Digital solutions with high level of expertise and critical thinking mindset. 

About you

• Education & Experience: Bachelor’s degree in an Engineering, Computer Science, or Digital/IT discipline.

• 8+ years of experience in Audit / inspection experience in regulated GxP computerized systems environments.

• 8+ years of experience in Quality Management, Computerized Systems compliance (GxP, SOX, Data Privacy, Cyber), or Information Technology contributing to regulated projects or system lifecycle activities.

• 4+ years of experience working in the Life Sciences industry

• Certified Internal Auditor, or Certified Information Systems Auditor certification preferred

• Soft skills: Excellent organizational and communication skills

• High level of proactivity and autonomy with ability to alert

• Stakeholder management

• Adaptability to a changing and highly dynamic work environment

• Strong critical thinking and problem-solving skills

• Demonstrated leadership skills and ability to effectively influence and make decisions, in a global setting

• Pragmatic and results-driven

• Professional communication and writing ability in English

• Technical skills: Audit / quality assurance / inspection experience

• Advanced knowledge of quality management & compliance, industry best practices (e.g. GAMP 5), and GXP and Sarbannes Oxley regulations applicable to computerized systems

• Understanding of relevant life sciences IT risk domains and controls (e.g., Privacy, Security)

• Hands on knowledge of IT lifecycle approaches (including Agile practices); experience in systems validation and required controls to mitigate risks to compliance. Understanding of quality agreements.

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Expand your impact beyond our Digital Risk & Compliance team: our aim is, by ensuring Risk & Compliance at the speed of the business, to support the Digital transformation with a One Sanofi objective to halve the time from discovery to therapy. 

• Get the opportunity to work in an international environment, into a dynamic team, fully empowered to propose and implement innovative ideas. This role will also provide the Digital Risk & Compliance Lead with hands-on experience on collaborating with diverse business teams and vendors.