Budapest, HUN
1 day ago
Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator - VIE Contract
**Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator - VIE Contract** + Location: Hungary, Budapest + Target start date: 01/04/2026 _iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28._ _PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship._ _PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address._ **About the job** _As_ **_Regulatory Continuous Improvement Performance (CIP) – Audit & Inspection Readiness Coordinator VIE_** _within our Regulatory team, you will join the Regulatory Compliance & Performance Office team part of the Global Regulatory Affairs (GRA), working on three key areas: audit & inspection readiness, quality management of the service providers and business quality representative (BQR) for computerized systems project._ _Join the engine of Sanofi’s mission — where deep immunoscience meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could turn the impossible into possible for millions._ _Ready to get started?_ **About Sanofi** _We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives._ **Main responsibilities:** + Act as key contact point with internal Quality organizations to prepare and ensure follow-up of audits and inspections. + Coordinate and provide direct support to regulatory departments audited/inspected in all phases of audit and inspection process through preparatory and supporting activities. + Liaise with concerned regulatory departments to elaborate relevant Corrective Actions and Preventive Actions (CAPAs). + Assure monitoring of CAPAs and organize CAPA Effectiveness Review when appropriate. + Participate in development of trend analysis on audit and inspection results. + Provide initial training on audit and inspection readiness for Subject Matter Experts (SMEs) who have no prior experience on this topic. + Lead best practices sharing and lessons learned following audits and inspections. Manage communication roadmap for audit & inspection readiness. + Conduct Quality Risk Assessments (QRAs). Maintain quality management tool for Service provider up-to date. + Support the role of the Business Quality Representative (BQR) in computerized systems projects. **About you** **Experience:** + Regulatory Affairs and/or Quality experience is a plus. + Knowledge of Microsoft Office and Windows tools (Outlook, Word, Excel, PowerPoint, Teams); experience with Power BI is a plus. **Soft and Technical skills:** + Clear and effective communication, both written and spoken. + Team collaboration and cross-functional working abilities in an international environment. + Demonstrated capacity to learn quickly and apply new knowledge effectively. + Proactive and problem-solving attitude. + Organizational skills, able to manage multiple tasks and deadlines. + Strong attention to detail and accuracy. + Continuous Improvement Mindset. **Education:** + Master's degree in Life Sciences, Engineering (Chemical, Biomedical, Industrial), Pharmacy, Chemistry, Biology, or other related scientific/technical fields. **Languages** : + Fluent English (written and verbal). **Why choose us?** + Be part of a pioneering biopharma company where patient insights shape drug development. + Work at the forefront of AI-powered science that accelerates discovery and improves outcomes. + Collaborate beyond your expertise, sparking new ideas with diverse, multidisciplinary teams. + Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science. + Help improve the lives of millions of people globally by making drug development quicker and more effective. + Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs. + Achieve genuine work-life balance in a supportive R&D environment. iMove is a unique program tailored for European youth interested in challenging themselves with meaningful assignments across the globe. At Sanofi we have a strong ambition to invest in young talents who will drive the success of Sanofi tomorrow. Sanofi’s Work Abroad Program, iMove, offers jobs-assignments with actual responsibilities and a perspective to grow. We provide those opportunities in various functions such as: marketing, finance, regulatory, supply chain, clinical trials, production, etc. and in more than 40 countries. Sanofi unites people who are passionate about solving healthcare needs across the world. Joining our iMove Work Abroad Program is a unique opportunity to make a difference through your work. \#LI-EUR **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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)
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