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Sanofi U.S.

Digital Risk & Compliance Lead - Controls Assurance

Dabas, Hungary

Job title: Digital Risk & Compliance Lead - Controls Assurance

  • Location: Budapest - Sanofi Business Services, Váci Greens

About the job

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Join our Digital Risk & Compliance team as Digital Risk & Compliance Lead - Controls Assurance and you can help make it happen. Our mission is to drive Digital Risk & Compliance to protect patient safety and Sanofi growth. Your job? You will be responsible todrive the execution of assessment and testing campaigns (GxP Periodic Reviews, Third Party Assessments) to demonstrate risk & compliance health across the Digital solutions and/or third-parties portfolio.

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Main responsibilities:
  • Support both tactical and strategic elements ofGxP Periodic Reviewsprocess
  • Oversee, monitor and report onGxP Periodic Reviews plan progress via the maintenance of dedicated KPIs
  • Escalate execution issues and alerts as needed
  • Improve GxP Periodic Reviews process with a continuous improvement mindset, exploring synergies with other controls assurance functions (Third Party Assurance), and enable transformation and automation
  • Execute Periodic Reviews of GxP regulated Digital solutions
  • Identify compliance risks and areas of improvement
  • Evaluate the adequacy of designed controls
  • Support the execution of third party quality assessments and audits (typically remotely)

About you
  • Experience: 8+ years of experience in Audit / Quality Assurance / inspection experience in regulated GxP computerized systems environments, 8+ 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
  • Technical skills: Audit / Quality Assurance / 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, 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
  • Soft skills: 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, 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
  • Education: Bachelor's degree in a scientific, engineering or Digital/IT discipline
  • Languages: Fluency in English

Why choose us?

Add four standard Sanofi selling points and up to three additional selling points that are specific to the role, team or location.
  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
  • An attractive, market-oriented salary and cafeteria benefits
  • Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
  • Work from an "Office of the Year 2020" finalist office

Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together.

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

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

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people's lives. Please ensure to have read this document, before applying.

#Sanofi #WeNeverSettle #SanofiCareers #PursueProgress #DiscoverExtraordinary #joinsanofi #careerswithpurpose #SBSBUDAPEST #LI-EUR #LI-Hybrid

Client-provided location(s): Hungary
Job ID: Sanofi-https://jobs.sanofi.com/en/job/budapest/digital-risk-and-compliance-lead-controls-assurance/2649/13696832256
Employment Type: Other