Digital Risk & Compliance Expert - Controls Assurance

Job title: Digital Risk Compliance Expert - Controls Assurance

About Sanofi

Sanofi is an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people s lives. Our teams across the world strive to transform the practice of medicine, turning the impossible into the possible for patients. We provide potentially life-changing treatments and the protection of life-saving vaccines to millions of people, and affordable access to our medicines in some of the world s poorest countries.

About the job

Our Team:

Within Digital Risk Compliance, we are looking for a Digital Risk Compliance Expert - Controls Assurance.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 demonstrate risk compliance health across critical digital solutions and/or third parties by providing proactive operating effectiveness insights of Digital controls through real-time monitoring and assurance. Where real-time monitoring is not yet available, we are conducting assessment testing campaigns to check effectiveness of controls mitigating Digital risks (i.e.: Product Quality Patient safety, Financial, Cyber risks )

What you ll be doing:

The Digital Risk Compliance Expert - Controls Assurance will be responsible to support the execution of campaigns (GxP Periodic Reviews, Third Party Assessments) to demonstrate risk compliance health across the Digital solutions and/or third-parties portfolio.

The DRC team is composed of around 60 team members. Your impact would go way beyond this 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.

This role provides an 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 DRC expert with hands-on experience on collaborating with diverse business teams and vendors.

Main responsibilities:

GxP Periodic Reviews

• Conduct activities related to the execution of GxP Periodic Reviews with a high level of expertise and critical thinking mindset

• Support the operational elements of the GxP Periodic Reviews process

• Identify compliance risks and areas of improvement

• Evaluate the adequacy of designed controls with a continuous improvement mindset

• Lead the improvement of the GxP Periodic Reviews process with a continuous improvement mindset, exploring synergies with other controls assurance functions (Third Party Audit), and enable transformation and automation

• Ensure proper and timely reporting of GxP Periodic Reviews plan progress via the maintenance of dedicated KPIs

• Escalate execution issues and alerts as needed

Third Party Assessments

• Support the execution of third party quality assessments and audits (typically remotely)

• Identify compliance risks and areas of improvement and evaluate the adequacy of designed controls, drawing conclusions and presenting findings to Third Party Audit team

• Contribute to develop and maintain controls assurance processes, implement opportunities for automation, and harmonize approaches across risk domains

The position is based in the above mentioned location with the opportunity to collaborate with internal and external stakeholders located all around the globe.

About you

• If you are passionate about Digital/IT and Quality, if you want to make a difference in how we work, you should come and join a dynamic team with great values!

• Based on prior experience of the selected applicant, upskilling opportunities will be provided.

• E ducation Experience

• Bachelor s degree in a scientific, engineering or Digital/IT discipline

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

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

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

• Technical skills :

• Audit / QA / inspection experience

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

• Advanced knowledge of quality management compliance, industry standards, 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

Soft skills :

• 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

• Excellent written and oral communication in English

• Strong interpersonal skills to effectively communicate and build effective relationships with a variety of stakeholders

• Excellent organizational and communication skills

• Rigor and assertiveness with the ability to present in an impactful way

• High level of proactivity and autonomy with ability to alert

• Pragmatic and results-driven

• Languages: English is mandatory

Sanofi Behaviors and Skills

This position is required to demonstrate behaviors such as Stretch, Put the interest of the organization, Act in the interest of our patients and customers and Take Action. During the interview we will also be asking for examples of skills such as Strategic Thinking, Result Orientation, , Relationship and Influence.

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn t happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com !