Job Title: Batch Release Lead
Location: Framingham, MA
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.
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)
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/Qualifications
Expected Experience
BA Degree with 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
Expected Technical skills
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
Language
Local language and English
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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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:
$108,750.00 - $157,083.33All 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.