Job title: Quality Business Partner

Location: Moosic, 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 Quality Business Partner is to have a Quality mindset and culture across the organization, creating right-first time solutions which enable high business impact initiatives, and establishing competitive advantage by informing the business of prioritized, relevant risks to ensure they are effectively managed

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:

Implement an off-the-shelf 2-8C shipper to be used for non-Sanofi / VaxServe shipments.

Identification and assessment of potential shipper solutions

Qualification / validation of selected solution

Develop and provide packout configuration to distribution centers.

Partner/coordinate with commercial team when new products being brought into the portfolio. Develop new product launch process for VaxServe.

Develop and implement quality procedures for VaxServe

New product launch

Recall of non-Sanofi products

Management of master data

Management of serialization requirements and resolution of issues

Integrate VaxServe commercial team into applicable Sanofi quality systems

Initiate and manage Events/CAPA records related to commercial team

Initiate change controls for new product launches or other changes.

Manage supplier CAPAs

Establish and manage quality agreements with existing suppliers. Update or initiate new quality agreements during new product launches.

Participate and represent VaxServe for internal and external audits/inspections.

Shared accountability in longer-term objective to identify/build box (boxes) that could be used for Sanofi and non-Sanofi vaccines that can be used also from Sanofi side.

About You

Education and Experience:

Minimum bachelor’s degree from an accredited four-year college or university

Experience working in regulated Pharmaceutical /Biotechnology / Medical Devices or Life Sciences industry in a Quality/Compliance-related role and/or in one or more of GxP/GMP/GCP areas.

Base knowledge of one or more Quality Systems (i.e. CAPA, deviations, recalls..).   

15% travel, Bridgewater, NJ until March then Morristown, NJ thereafter.

Preferred experience, previous Quality experience and knowledge of Health Regulated and GXP activities is preferred. Experience for Health Regulated or GXP activities is preferred. Experience with Good Distribution Practices and Shipping Validation is preferred.

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.