What are the responsibilities and job description for the Quality Assurance Manager position at Sanofi?
Job title : Quality Assurance Manager
Location : Ridgefield, NJ
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 Quality Assurance Manager within our Biosurgery Quality Team will be to ensure compliance with cGMP, regulatory, and internal requirements regarding the manufacturing, testing, and distributing of products through formal QA walkthroughs, Audits and Investigations that may result in additional training and recommendations to procedural improvements. Evaluate and provide QA recommendations for all products, systems, facilities, and issues that are affected or may be affected by regulatory or cGMP requirements.
Increase quality culture in the manufacturing areas. Enhance technical knowledge of operators and shop floor managers by providing positive and constructive feedback.
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 :
- Managing shopfloor team and day to day QA activities
- Assist in enhancing the program and continuously improve
- Establish walkthrough and audit scheduling and building support for both Sanofi locations.
- Drive the QA shop floor program and address concerns with manufacturing and driving quality improvements
- Trend observations and drive proper actions to closure with manufacturing
- Review findings with area owner and drive continuous improvement
- Escalate results to management
- Mentoring and coaching QA Shopfloor personnel
- Coaching manufacturing team, when required
- Collaboration with manufacturing on process improvements
- Area / Line clearances, when required
- Review documentation- BPRs, Logbooks
- Deviation support, when required
- Perform audits, walk-throughs, GEMBAs, technical coaching
- Support Associate Director with task such as change controls, meeting coverage, deviations
- Support Additional Quality functions (Media Fill Observer, Documentation Updates etc)
- Author significant and non-significant deviations, change controls, report etc.
- Present department KPIs as needed
- Support other additional activities as needed (Management Review, presentations etc).
About You
Basic Qualifications / Requirements :
Preferred Qualifications :
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.
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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.
