• Location: Prague, Czechia
• Job type: Permanent, full-time
• Flexible working: Hybrid (3 days in Prague office, 2 days home office)

About the job

As a CMO Quality Manager within our External Manufacturing & Supply (EM&S) General Medicines Europe team, you will play a key role in ensuring that our Contract Manufacturing Organisations (CMOs) consistently deliver products that meet Sanofi’s quality, safety, and compliance standards. You’ll be part of a global virtual site, collaborating with cross‑functional partners across Quality, Supply Chain, procurement, finance, and manufacturing to ensure seamless, compliant product supply. Ready to get started?

Join the team transforming how healthcare is delivered for chronic and speciality conditions worldwide. In General Medicines, you’ll help drive meaningful outcomes with the scale and urgency patients deserve.

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 the Quality representative in internal core teams (Supply Chain, KAM, Finance, Global Quality) and in joint meetings with CMOs.
• Manage quality events from CMOs, reviewing investigation reports to ensure proper assessment of criticality, root cause, impact, and CAPA effectiveness.
• Evaluate and confirm the CMO's decisions regarding the final batch disposition on behalf of Sanofi.
• Manage internal quality events and related quality alerts, including those triggered by OOS results in IPC/FP testing, stability studies, or others defined by Sanofi QMS.
• Review and assess Change Controls as a quality expert, participating in CC committees and ensuring timely implementation and closure.
• Review, update, and maintain Quality Agreements with CMOs and business partners, ensuring compliance for all delegated Manufacturing & Supply activities.
• Support CMOs during regulatory inspections when required.
• Ensure timely update of CMO‑related information within Sanofi’s Quality Management System.
• Serve as a Subject Matter Expert (SME) and active member of the Quality Community of Practice—implementing standardised processes, supporting end users, and acting as the “voice of the customer” to drive simplification and harmonisation.

About you

• Minimum 5 years of experience in a cGxP or other regulated environment for biotechnology or aseptic pharmaceutical products, ideally in an on-site Quality or Production.
• Strong understanding of pharmaceutical regulations, GxP requirements, and application across the product lifecycle from material supply through to market entry.
• Excellent problem‑solving skills with demonstrated capability in root‑cause analysis and corrective/preventive action implementation.
• Ability to make independent decisions, exercising sound judgment and autonomy.
• Strong communication and collaboration skills when working with both internal teams and external partners.
• Fluency in written and spoken English required; additional languages (especially French) are an asset.

Why choose us?

• Drive meaningful impact at a global scale: our medicines reach more than 100 million people each year.
• Be part of a simpler, digital‑ and AI‑powered business that’s rethinking how we work and engage with the world.
• Stretch your career in a development playground, with opportunities across functions, regions, and the entire product lifecycle.
• Contribute directly to the reliable supply of high‑quality medicines through close engagement with CMOs—giving you broad exposure across manufacturing, quality, and operations.

#LI-EU

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!