Batch Release Operations Lead

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

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