EM&S Vaccines Quality Lead - Person in Plant

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.