Batch Release Lead

Batch Release Lead

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We are an innovative global healthcare company with one purpose : to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities

• Overseeing the batch release process to ensure compliance with regulatory requirements and company standards
• Overseeing review and approval of batch records and associated documentation
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Conducting risk assessments and implementing mitigation strategies for batch release processes
• Participating to coordination of actions across teams (Quality Control, production) to ensure lot release in a timely manner following flow controller priorities
• Investigating and resolving any issues or deviations related to batch release (including temperature excursion evaluation per product if distribution channel faces an unusual event)
• Participating in internal and external audits and inspections
• Collaborating with regulatory affairs to ensure compliance with local and international regulations
• Monitoring and analyzing batch release performance metrics
• Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness
• Participating in Quality Alert / Product Alert meetings and ensuring that investigation and actions taken during those meetings allow the decision for disposition of lots
• Representing the site in the CoP led by global and, if requested, participating in the CoE and ensuring local communication
• Point of contact within operational team for complaint investigation when needed on site (coordination of investigation report)

Key Involvement in Decision Making Process

Key roles (D,A,I)

About You

Requirements / Qualifications

Expected Technical Skills

Language

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.