Operations Batch Release Team Leader

Job Title: Operations Batch Release Team Leader

• Location: Waterford, Ireland
• Job Type: Full-Time,23-month Fixed-Term Contract

About the job

As a OperationsBatch Release Team Leader, you play a critical operational leadership role within Lyo Operations, driving end-to-end batch release performance, deviation management, and cross-functional collaboration across internal teams and external stakeholders supporting Rare Disease, Rare Blood Disorder, and General Medicines.

You are accountable for ensuring that release cycle time targets - including Operational Cycle Time (OCT) and Plant Cycle Time (PCT) - are consistently achieved. You deliver this through strong cross-functional performance governance, structured deviation management, and by fostering a culture of effective collaboration.

You act as the central coordination point across all functions involved in the batch release process. While you are not directly accountable for the performance of other departments, you are responsible for establishing and maintaining the governance framework that enables each function to meet its commitments. This includes identifying performance gaps, escalating risks, and driving corrective actions where required.

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 treatments reach people everywhere, faster.

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:

Batch Release & Cycle Time Performance

• Own the end-to-end batch release process, ensuring all activities are completed within defined lead times to achieve OCT and PCT targets
• Monitor and report on release cycle time performance, identifying bottlenecks and driving resolution across functions
• Lead the Comments Clinic process to ensure all batch record comments are closed on time, eliminating risk to batch release
• Serve as the APU lead for batch release process standards, ensuring alignment and compliance across the team
• Support delivery of product-specific PCT targets (e.g., Myozyme, ALtuviiio etc) in collaboration with cross-functional partners

Cross-Functional Performance Governance

• Design, implement, and maintain a performance governance framework that tracks lead time adherence across all functions contributing to batch release
• Facilitate standard governance meetings (daily, weekly, and periodic cadences) to review performance, surface risks, and coordinate action
• Hold functions accountable to their commitments through structured follow-up and escalation processes — without direct line accountability for those functions
• Drive improvements in meeting effectiveness and cross-functional coordination efficiency
• Serve as the primary escalation point for release-related performance issues requiring multi-functional resolution

Deviation Management

• Provided combined management oversight for the Deviation Team (along with Head of PCU Engineering), ensuring all deviations are managed within defined lead times and closed on time or formally extended with appropriate justification
• Facilitate daily and weekly deviation review meetings to drive timely closure and continuous reduction in open deviation volumes
• Serve as the APU lead for deviation process standards, ensuring consistency and compliance across Operations, Engineering, and Quality functions
• Maintain and improve deviation management compliance metrics, targeting sustained reduction in open and overdue deviations

People Leadership & Team Development

• Lead, develop, and engage the Deviation Team, maintaining a high-performance culture aligned with Sanofi values
• Maintain a structured training plan for the team, spanning Operations, Engineering, and Quality disciplines, with a target of ≥95% training compliance
• Conduct regular 1:1s and team communications to ensure alignment, engagement, and development
• Foster a strong safety culture, ensuring zero Lost Time Incidents (LTI) and full compliance with HSE standards, life-saving rules, and mandatory safety verifications (MSVs)

About you

• Degree in Life Sciences, Engineering, Pharmacy, or a related discipline
• Significant experience in a biopharmaceutical or pharmaceutical manufacturing environment, with direct exposure to batch release and/or quality operations
• Demonstrated experience in cross-functional coordination or operational governance roles
• Proven track record of leading continuous improvement initiatives, with measurable outcomes in cycle time, quality, or productivity
• Experience managing or coordinating deviation, CAPA or Change Control processes in a GMP-regulated environment
• Familiarity with external improvement frameworks (e.g., McKinsey Accelerator, Lean, Six Sigma, or equivalent) is highly desirable
• Strong data literacy - ability to build and interpret performance metrics and drive action from data
• Experience leading or developing small-to-medium teams in an operational setting
• Knowledge of Lyophilisation and associated processes or biologics manufacturing processes is an advantage

Why choose us?

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.
• 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, with pride.

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