Quality Business Partner

Job title: Quality Business Partner

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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