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Sanofi Group Compliance Specialist Senior-Ridgefield, NJ in Ridgefield, New Jersey

Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets and animal health.

The Compliance Specialist will be responsible for tracking the status of product deviations, leading root cause analysis activities, approving deviations reports and providing technical support to Operations. In addition, this role will be responsible for creation, review and approval of CAPAs and Effectiveness Checks.

Responsibilities:

  • Collaborate with Quality, Subject Matter Experts (SME) and Manufacturing as required; determine the scope of the investigation.

  • Leading and authoring complex technical investigations (and investigation team) to ensure regulatory compliance

  • Provide Quality technical expertise to assist manufacturing investigations associated with OOS/OOTs, Utility Interruptions, Environmental Monitoring excursions

  • Develop investigation strategy and complete within required timeline

  • Proficient in Root Cause Analysis Techniques

  • Perform detailed analysis of data, trends and systems

  • Classification, review and approval of deviations

  • Support investigations of minor non-conformance

  • Present investigation to Quality Review Board

  • Creation and approval of CAPAs to ensure Root Cause is properly addressed

  • Provide guidance and training to personnel performing deviation and CAPA activities

  • Authoring and updating SOPs to maintain compliance to corporate standards, and cGMP requirements

  • Trending of deviation and CAPA reports, and recommendations per results

  • Perform basic statistical analysis.

  • Generate deviation and CAPA Metrics, and present as needed

  • Support regulatory body audits

  • Responsible for QA Project Management of Deviations, and subsequent CAPAs.

  • Understands very complex and explicit documentation, and able to convey in a concise manner.

Basic Qualifications:

  • A Bachelor’s Degree required with 8 or more years experience OR

  • A Master’s Degree with 6 years or more years' experience in Quality Assurance environment

  • Working knowledge of cGMPs in pharmaceuticals/biological and aseptic manufacturing

  • Leading Investigation Team

  • Works independently to ensure on-time investigation closure

  • Basic knowledge of Statistics and Trending

Preferred Qualifications:

  • Preferred experience with Lean, 5S and Gemba for CAPA

  • Preferred experience with a deviation/CAPA enterprise system (Trackwise, SAP, etc)

Other skills:

  • Strong communicator

  • Working knowledge of Word, Excel, PowerPoint

  • Excellent technical writing skills

  • Strong analytical and problem solving skills

  • Make sound judgement from data

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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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.

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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