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 Operations Batch 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.

#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 and check out our Diversity Equity and Inclusion actions at sanofi.com !

The salary range for this position is :€54 800,00 - €73 067 Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.