Job title: Digital Risk & Compliance Expert – 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 Expert – Control Assurance”. This person will be responsible for driving risk & compliance assurance across the Digital solutions and services third parties portfolio. He/She will be particularly focused on hands-on execution of quality assessments and audits of our third-party providers.

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 Expert 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: Plan, organize, and execute third party quality assessments and audits (typically remotely) in collaboration with risk partners (Cyber Security, Data Privacy)

  • Identify risks and areas of improvement and evaluate the adequacy of designed controls, drawing conclusions and presenting findings in formal written reports and summaries

  • Track, and ensure corrective actions are implemented by the third party in a timely manner to effectively address identified issues

  • Participate in the execution of quality agreements with third parties based using a risk-based approach

  • Third Party Quality Management: Design and administer a Digital third-party database to track and maintain qualification status and track status of monitoring activities

  • Manage and maintain audit and third-party records in the Quality Management System.

  • Contribute to governance, planning, preparation, hosting, and response activities

  • GxP Periodic Reviews execution​: Execute Periodic Reviews of GxP regulated Digital solutions with high level of expertise and critical thinking mindset

  • Identify compliance risks and areas of improvement

About you

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

  • 4+ years of experience in Audit / Quality Assurance / inspection experience in regulated GxP computerized systems environments

  • 4+ 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

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

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

  • Soft skills: Internal Stakeholder collaboration and third-party relationship management

  • Strong critical thinking and problem-solving skills

  • Adaptability to a changing and highly dynamic work environment

  • Pragmatic and results-driven

  • Demonstrated organizational skills and ability to make a risk based analysis and informed decisions and recommendations, in a global setting

  • Regular (2-3 days per week) flexibility to be available to remotely conduct assessments and team meetings during Europe time zones (afternoons), and U.S Eastern Time zones (mornings)

  • Technical skills: Audit / quality assurance / inspection practical experience

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

  • Knowledge of quality management & compliance, industry standards, Sarbannes Oxley and GXP regulations applicable to computerized systems

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

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 @the speed of the business, to support the Digital transformation with a OneSanofi 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 expert with hands-on experience on collaborating with diverse business teams and vendors.