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Sanofi Group Senior Quality Auditor in Framingham, Massachusetts

Position Title - Senior Quality Auditor

JOB OVERVIEW

Quality business partner that ensures compliance with applicable GLP regulations, GCLP guidance, SOPs, and Sanofi policies by auditing non-clinical safety studies, analysis of clinical samples, processes and facilities at Sanofi US R&D sites and contract laboratories. You will serve as a resource for GLP and GCLP compliance and quality issues and will represent the organization by providing quality guidance on assigned projects.

RESPONSIBILITIES

  • Audit laboratory activities, support services, data, and reports. Prepare audit reports, assure corrective actions are complete and solutions are consistent with the organizational objectives

  • Assess external vendors and suppliers contracted by Sanofi for GLP and GCLP activities to ensure appropriate level of compliance

  • Contribute to working groups at local and/or global level that work on the development of new concepts, techniques, and standards within the company

  • Responsible for ensuring our GLP and GCLP data and facilities comply with FDA and other foreign health authority regulations/guidelines, Sanofi policies and procedures, and industry standards as appropriate

  • Review quality documents including SOPs, policies, reports, methods and equipment and computer validation deliverables

REQUIREMENTS & QUALIFICATIONS

  • Bachelor of Arts/Science in related field

  • 5-8 years in a Quality and/or Operational role in a biotech/pharmaceutical GLP/GCLP environment

  • Ability to work independently and to establish solid working relationships with staff of all levels and disciplines

  • Understanding of GLP/GCLP regulatory requirements and guidance. Experience with non-clinical safety studies, clinical sample analysis, and validation and performance of bioanalytical methods. Knowledge of industry practices pertaining to the validation and qualification of laboratory equipment

  • Auditing experience including the ability to audit computerized data

  • Manage multiple duties often under challenging timelines

TERMS OF EMPLOYMENT

  • Full time

  • Domestic travel up to 20%

  • Start Date- As soon as possible

  • Working hours- Business hours

WHAT MAKES THIS POSITION UNIQUE?

You are member of the only GLP Quality group in the US. It is a small group with many responsibilities which will allow you exposure to the quality role that is involved with the development of a product at Sanofi and will allow you to develop new skills. You will have the opportunity to directly contribute to process improvements and make changes that will benefit QA and our partner groups.

BENEFITS OF WORKING IN THIS ROLE

  • Position supports career growth within the quality organization and provides development in regulatory compliance

  • Opportunity to work with a variety of disciplines involved in development as well as exposure to global teams

  • Work as a team with our partner groups to directly support Sanofi science, strategy, and ultimately our patients

LOCATION INFORMATION

  • Job is currently located in Framingham, MA but candidate must be willing to relocate to Cambridge, MA

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.

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