Operations Batch Release Team Leader

Sanofi; France; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Sanofi is seeking an Operations Batch Release Team Leader in Waterford, Ireland, to drive end-to-end batch release performance and cross-functional collaboration across Rare Disease and General Medicines. You will govern release cycle times (OCT and PCT), manage deviations, and lead a high-performance team within Manufacturing & Supply.

The role emphasizes governance, timely closure of batch record comments, and continuous improvement of cycle times and quality metrics, while maintaining a

Qualifications

• 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.

Responsabilités

• Own the end-to-end batch release process to achieve OCT and PCT targets.
• Monitor release cycle time and drive cross-functional resolution.
• Lead the Comments Clinic to close batch record comments on time.
• Serve as the APU lead for batch release standards and governance.
• Design and maintain a governance framework tracking lead time across functions.
• Facilitate governance meetings to review performance and risks.
• Escalate risks and ensure action for multi-functional resolution.
• Lead the Deviation Team and ensure deviations are closed on time.
• Maintain training plans and ensure safety and MSVs.

Connaissances

Cross-functional coordination

Operational governance

Continuous improvement

People leadership

Quality operations

Formation

Degree in Life Sciences, Engineering, or Pharmacy

Description du poste

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.

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.

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
• Fam

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.