Sanofi
This range is provided by Sanofi. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $125,250.00/yr - $180,916.66/yr
Job Title Batch Release Lead
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.
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 in 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 escape 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)
Requirements About You
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, PowerPoint, 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.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please click here.
Pursue
Progress.
Discover
Extraordinary.
Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done‑before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s pursue progress and discover extraordinary – together.
Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Sanofi by 2x
Get notified about new Quality Assurance Lead jobs in Swiftwater, MS.
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Base pay range $125,250.00/yr - $180,916.66/yr
Job Title Batch Release Lead
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.
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 in 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 escape 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)
Requirements About You
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, PowerPoint, 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.
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in company employee benefit programs, and additional benefits information can be found here.
Sanofi US endeavors to make our career center accessible to any and all users. If you are experiencing difficulty and need assistance applying online, please click here.
Pursue
Progress.
Discover
Extraordinary.
Join Sanofi and step into a new era of science – where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never‑been‑done‑before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s pursue progress and discover extraordinary – together.
Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Sanofi by 2x
Get notified about new Quality Assurance Lead jobs in Swiftwater, MS.
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr