_Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail._ _This job offer is accessible to all, regardless of gender._ **Job title:** _Cadre Assurance Quality - R&D CMC Synthetics_ + _Location: Sisteron, France_ + _Remote working: Up to 20% remote working possible_ + _Travel expected: 5-10%_ **_About the job_** Ready to shape the future of medicine? Join our R&D GQO team in Sisteron where we implement a quality management system adapted to early development phases. As a **Cadre Assurance Quality - R&D CMC Synthetics** , you'll make critical quality decisions based on scientific approach and rigorous risk assessment, balancing compliance requirements with necessary agility. Your expertise will be instrumental in ensuring our R&D CMC activities meet the highest quality standards while maintaining the flexibility needed for innovation. **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. **Key responsibilities:** + Manage Quality Assurance withint he R&D CMC Synthetics Sisteron + Maintain R&D quality management system processes within &D CMC Synthetics scope (compliance with regulatory requirements and internal standards, quality procedures and documents, Conducts self-inspections and monitors corrective actions implementation) + Coordinates investigations following deviations and non-conformities + Manage Change control + Review Clinical batch manufacturing records, Manufacturing Master Records or Technical Conditions + Performs Quality Agreements for subcontractors; Manages supplier quality issues and monitors corrective actions; Conducts supplier audits + Supervise analytical activities for R&D products: reviews and approves analytical methods and specifications; Participates in out-of-specification results and deviation investigations; Supports analytical method transfers + Prepares and participates in internal and external audits or regulatory inspection preparation + Conducts quality training + Applies group HSE policy within scope of activity; Promotes HSE best practices **_About you_** **Experience:** + 3-5 years experience in quality assurance in pharmaceutical industry, particularly in clinical API manufacturing + In-depth knowledge of GxPs applicable to clinical API manufacturing and analysis **Education** **:** + Mastery of quality processes and continuous improvement tools + Educational Background: Master's degree in scientific field (pharmacy or chemistry) or equivalent **Soft and technical skills** **:** + Knowledge of pharmaceutical regulations + Analysis and problem-solving capability + Strong communication and project management skills + Rigor and organizational skills + Ability to work in multidisciplinary teams + Proficiency in quality IT tools **Languages** **:** + Good level of English (B2/C1) **_Why choose us?_** + Give life to science miracles as part of a forward-thinking, supportive team + Discover countless opportunities to develop your talents and advance your career through promotion or cross-organizational assignments + Benefit from a well-thought-out package of benefits that recognize your contribution and amplify your impact + Take good care of yourself and your family with comprehensive health and wellness benefits, including high-quality healthcare, wellness programs, and parental leave of at least 14 weeks regardless of gender + Play a key role in establishing best practices within our production unit **Pursue** **_Progress_** **.** **Discover** **_Extraordinary_** **.** Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue _Progress_ and 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, gender identity, protected veteran status or other characteristics protected by law. **\#LI-FRA** **\#LI-Hybrid** **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)