Job Title: Quality Lead – EM&S Vaccines Quality (Person-in-Plant) Location: Pune, India
About the job As a Quality Lead – EM&S Vaccines Quality (Person-in-Plant) within our Manufacturing & Supply (Vaccines Quality) team, you'll serve as the primary Quality representative supporting one of Sanofi's Contract Manufacturing Organizations (CMOs) in India. You'll provide end-to-end quality oversight, ensuring compliance with cGMP standards, regulatory requirements, and Sanofi Quality Systems while partnering closely with internal and external stakeholders to deliver safe, high-quality vaccines. Ready to get started? Join a global network that powers how Sanofi delivers—seamlessly, purposefully, and at scale. In Manufacturing & Supply, you'll help reimagine how life-changing vaccines reach people everywhere, faster, while contributing to a resilient, quality-focused global supply network.
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
• Serve as the primary Quality representative for assigned Contract Manufacturing Organization(s), providing quality oversight across manufacturing operations.
• Review and approve GMP documentation including batch records, deviations, CAPAs, change controls, validation documents, investigations, Product Quality Reviews, and technical specifications.
• Partner with internal and external stakeholders to ensure quality compliance throughout manufacturing, technology transfers, and product lifecycle activities.
• Monitor quality performance through key performance indicators, identify risks, and drive remediation and continuous improvement initiatives.
• Support internal audits, supplier audits, and regulatory inspections while ensuring timely resolution of quality and compliance observations.
• Lead the preparation and negotiation of Quality Agreements and provide quality support for batch disposition and release decisions.
• Represent the Quality function in governance meetings and cross-functional project teams, providing independent quality guidance and decision-making.
About you
• Experience: Experience in Quality Assurance within a cGxP-regulated pharmaceutical or biopharmaceutical manufacturing environment, including oversight of external manufacturing or Contract Manufacturing Organizations (CMOs) and people leadership.
• Soft and technical skills: Strong knowledge of cGMP, Quality Management Systems, deviations, CAPA, change control, validation, investigations, quality risk management, and regulatory compliance. Excellent stakeholder management, communication, negotiation, problem-solving, and decision-making skills with the ability to work effectively in a matrix organization.
• Education: Bachelor's degree in Pharmacy, Life Sciences, Biotechnology, Chemistry, Engineering, or another relevant scientific discipline.
• Languages: Native proficiency in an Indian language and fluent English.
Why choose us?
• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• Power industry-leading performance by leveraging digital, data, and AI-driven innovation—at speed and scale.
• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.
• Grow, thrive, and make an impact in a workplace that empowers you to bring your best self every day.
• Play a critical role in ensuring quality and compliance across Sanofi's global vaccine manufacturing network.
• Partner with global quality leaders, manufacturing teams, and strategic external partners to drive operational excellence.
• Build your career in a highly collaborative, international environment with opportunities to influence quality strategy and continuous improvement.
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!