Overview
Quality Business Partner Jobs in Bridgewater, Massachusetts, USA at Sanofi
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 / Vax Serve 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 Vax Serve.
Develop and implement quality procedures for Vax Serve.
New product launch.
Recall of non-Sanofi products.
Management of master data.
Management of serialization requirements and resolution of issues.
Integrate Vax Serve 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 Vax Serve 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 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.
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Title: Quality Business Partner
Company: Sanofi
Location: Bridgewater, Massachusetts, USA
Category: Healthcare, Quality Assurance – QA/QC
