Quality Assurance Batch Release Lead

Job Title: Batch Release Lead

Grade: L3

Hiring manager: Martin Razo

Location: Swiftwater, PA

About the Job

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. Your job, as QA Batch Release Lead within our Quality Assurance team, will be to lead and drive quality over the batch release process to market for the Swiftwater Site.

This role provides leadership and direction for quality oversight of the vaccine drug product manufacturing. This leadership role collaborates with a group of highly skilled and technical colleagues toward an inspiring mission of creating high quality life-saving vaccines.  The QA Batch Release Lead will lead a team of quality professionals overseeing final batch release and lot disposition for product distributed from the Sanofi Swiftwater Site and release from relevant Commercial Manufacturing Organizations (CMOs).  The Batch Release Lead will act as the Business Owner for Release processes.

Benefits of working in this role:

• Be part of an inspiring mission to create life-saving vaccines

• Leading a skilled and motivated team of quality professionals

• The work environment is a highly collaborative and technical vaccine manufacturing operation on a beautiful park like campus.

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)

• Manage all batch release activities including Final Release, Environmental Data Summary Review, Lot Release Protocol generation/approval, and CMO release as applicable.

Key Involvement in Decision Making:

• Approve documentation for batch disposition and update corresponding digital tool to allow release (D)

• Implement risk mitigation strategies to address potential quality issues in the batch release process (D)

• Resolve issues and deviations and take disposition decision on lots (D)

• Analyze performance metrics and escalate in case of issues (I)

• Informing senior management about batch release performance metrics and trends to support data-driven decision-making (I)

• Approve actions taken during Quality Alert meeting (D)

• Advise on complaint investigation (A)

About You

Requirements:

• Bachelor's Degree in Life Sciences or Engineering or equivalent

• 5 years of experience in a QA role within the pharmaceutical industry, with a focus on batch release processes

• Strong knowledge of Good Manufa