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Digital Quality Lead - Data Science

Company: Sanofi
Location: Bridgewater
Posted on: August 6, 2022

Job Description:

JOB OVERVIEW:The Digital Quality Lead - R&D Patient Data and RWE is a key member of the Digital Quality Operations team providing mission-critical Quality and Compliance expertise to the Digital Data Unit.The incumbent is the point of contact and Quality Partner for Digital Data interfacing with R&D and other business areas / Service Lines in Digital Data; she / he provides end-to-end Quality & Compliance oversight for this Digital Data business area by ensuring the delivery of Quality Services related to Project & Application Support, Audit & Inspection Support, Risk Management and Education & Compliance Readiness.This position covers an exciting and innovative Data business scope with a variety of Data solutions built on emerging technologies supporting R&D patient data and RWE/D generation and operations.The Digital Quality Lead provides expertise and guidance on Quality and Compliance related topics to application and project teams in a highly regulated and dynamic environment. The position requires detailed knowledge of and experience with regulations and software validation requirements in the Pharmaceutical/Biotechnology industry and the ability to successfully collaborate in a mufti-cultural team across locations and time zones.JOB QUALIFICATIONS:Bachelor's / Master's degree in Dngineering or any scientific discipline - Healthcare Industry specialty is desirable5 years of experience Quality Management, Computerized Systems compliance (GxP, SOX, Data Privacy) or Information Technology contributing to regulated projects or system lifecycle activitiesExperience with management of data integrity, data governance, and data management in a regulated context.As a healthcare company and a vaccine manufacturer, Sanofi has an important responsibility to protect individual and public health. All US based roles require individuals to be fully vaccinated against COVID-19 as part of your job responsibilities.Fully vaccinated, according to the CDC, an individual is considered to be "fully vaccinated" fourteen (14) days after receiving (a) the second dose of the Moderna or Pfizer vaccine, or (b) the single dose of the J&J vaccine. Fully vaccinated, for new Sanofi employees, is to be fully vaccinated 14 DAYS PRIOR TO START DATE. 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.GD-SGLI-GZ At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.PDN-96a373d9-64fe-4cf3-b701-7240353e18f9

Keywords: Sanofi, Trenton , Digital Quality Lead - Data Science, Other , Bridgewater, New Jersey

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