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 Manufacturing Practices (GMP) and quality assurance principles

Strong leadership experience - managing / developing high-performing teams in a matrix environment highly preferred

Ability to meticulously review batch records and documentation to ensure accuracy and compliance with regulatory standards

Proficiency in analyzing batch release performance metrics and identifying areas for improvement

Capability to investigate and resolve issues or deviations related to batch release processes efficiently

Experience in managing multiple tasks and projects simultaneously, ensuring timely completion of batch release activities

Exhibit and Champion for Sanofi Take the Lead Behaviors

Skills / Knowledge :

Ability to analyze complex data and identify trends, issues, and solutions

High level of accuracy and attention to detail in all quality assurance activities

Strong verbal and written communication skills for effective interaction with team members and regulatory bodies

Proficiency in identifying problems and implementing effective corrective actions

Ability to manage multiple projects simultaneously, ensuring timely completion and adherence to quality standards

Fluent English spoken and written compulsory local language fluency may be compulsory

Good knowledge of Swiftwater Plant operations

Ability to lead and influence at all levels

High level of autonomy

Strong Computer Literacy (including Microsoft excel, power point, word)

Why Choose Us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.

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.

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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 () !

US and Puerto Rico Residents Only

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.

North America Applicants Only

The salary range for this position is :

$125,250.00 - $180,916.66

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK () .

Global Terms & Conditions and Data Privacy Statement ()

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi ()

As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

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