Job Information
Sanofi Group Digital Risk & Compliance Expert – Controls Assurance in India
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.
Sanofi Group
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