+ **_Location:_** _Prague, Czech Republic_ + **_Hybrid:_** _60% office based, 40% remote_ + **_Type of contract:_** _Permanent, Full-time_ **_About the job_** Ready to push the limits of what's possible? Join Sanofi in our External Manufacturing GenMed Europe Quality & Regulatory department where you'll provide GxP oversight of Contract Manufacturing Organizations (CMOs) and business partners involved in the manufacture, testing, and transport of Sanofi products. You'll interact with multiple stakeholders to ensure compliance with internal and regulatory requirements while minimizing risk to quality and product supply. 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? **Main responsibilities:** + Lead CMO Quality Oversight for a portfolio of CMOs, providing guidance to operational teams on quality events, risk management, change control, product quality reviews, and complaints + Manage Sanofi CMO quality focal points team and ensure effective interaction with external & internal departments + Monitor CMO quality KPIs, contribute to annual quality evaluations, and prepare quality presentations for Business and Quality Reviews + Ensure proper management of quality issues, evaluate CMO decisions regarding batch disposition, and identify/track risks through defined processes + Oversee Product Quality Review and Product Complaint management for EM Europe portfolio, driving KPI monitoring and acting as subject matter expert + Promote digitalization of EM CMO Quality & post-release Quality activities + Select, develop, and motivate qualified staff while providing leadership, guidance, and direction consistent with cGMP and company quality governance **_About you_** + **Experience** : Extensive QA and QC experience, + Experience in a pharmaceutical manufacturing site or previous experience in CMO management + **Soft skills** : Ability to work in a matrix organization, strong interpersonal and communication skills with excellent command of English, strong networking abilities, leadership and assertiveness skills, decision making, and ability to identify situations requiring escalation + **Technical skills** : Excellent cGMP knowledge, in-depth knowledge of Pharmaceutical Operations, qualification as external auditor is a plus + **Education** : Bachelor's or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields + **Languages** : English spoken and written compulsory, with other languages welcomed (French is an asset) **_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 **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 (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) ! \#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)