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Quality Auditor Principal

Northborough, Massachusetts

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Overview

This is where ideas are pioneered and innovation takes shape. Where being a health journey partner takes shape — and where you can help bring ideas to life. Research & Development is the heart of our business. The clinical research, clinical development and clinical trials that are essential to new product development all happen here. Preclinical drug safety is rigorously tested and our program management teams ensure everything stays on track. Together, our R&D team ensures that our pipeline is protected and productive — and that the early stages of development run smoothly and effectively. Come be part of this journey.

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Benefits

  • Health & Wellness

    Comprehensive coverage including medical, dental, vision, and health and wellness programs.

  • Financial

    Sanofi wants to ensure employees are equipped for financial health, Sanofi provides a competitive 401K Match program and Financial Wel-Being Tools and Programs.

  • Culture

    At Sanofi, we demonstrate our commitment to inclusion and diversity through Culture groups and programs. There are many ways to make a difference and connect with other Sanofi employees: including ERG groups and 2 PAID days off to Volunteer.

  • Work/Life Balance

    Sanofi provides significant Work/Life benefits to help you excel beyond the workday. Including Workplace Flexibility through part‑time, remote work, flex‑time and job share options.

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Quote

"My family is everything to me. They are proud of the work I do, educating the community and ensuring that no Pompe patient is left behind."

C. Richard Cioci Clinical Science Associate – Pompe Ontario East & Atlantic

"I am continually impressed at the dedication that Sanofi has to the patients for whom we provide solutions."

Suncére Hernandez Area Business Manager, Multiple Sclerosis

"I give thanks to my powerhouse team for reminding me that I have a support system behind me, pushing me forward."

Bob Shustack Head of Global Support Functions Finance, North America

Responsibilities

See attached job description

The Northborough Supplier Quality department is comprised of the following functions:
 (1) Manage supplier audits consistent with Sanofi and industry expectiation. (2) Manage self inspections, external regulatory inspections and internal corporate audits (3) Manage Quality agreements, supplier change management, supplier material/service onboarding and approval (4) Data Integrity
 The Northborough Supplier Quality department provides stragegic leadership, direction and oversight for the NBO site compliance and ensures NBO inspection readiness in alignment with global good manufacturing practices, regulatory compliance requirements and current industry/Sanofi policy and guidance. The Supplier Quality department provides oversight of supplier management and lifecycle functions.

Position Overview with Key Responsibilities
A Quality Auditor Principal is responsible for providing supplier management oversight on behalf of the Sanofi network and NBO Self Inspection compliance in accordance with global good manufacturing practices, regulatory compliance requirements and guidance, current industry best practicecs and corporate policies.  

Key responsibilities include:

  • Scheduling and conducting Supplier audits and Self Inspections, produce reports and follow up on non-compliant issues.  These audits may include GLP, GMP and/or ISO 13485 compliance evaluations
  • Support corporate audits and external inspections  
  • Implement Supplier change notifications, new material/service/supplier onboarding, and quality agreements
  • Read and interpret complex, explicit docuemtnation for new and current compliance procedures and regulatory enforcement trends/actions
  • Assist in solving compliance problems with R&D, QA, QC, Facilities and/or


Basic Qualifications

  • Bachelor’s degree
  • 7-9 years of experience in Quality Assurance in a GMP environment.

Preferred Qualifications

  • Master’s Degree
  • American Society for Quality (ASQ) Certified Auditor
  • Experience participating or leading in Self Inspections / Supplier Audits / Regulatory Inspections
  • Experience with Quality Events (deviations, CAPA, etc)
  • Ability to work independently  
  • Knowledge of regulatory enforcement trends and industry compliance trends
  • Experience with project management
  • Special Working Conditions
  • This position requires domestic travel and may include occasional international travel.
  • Ability to gown and gain entry to manufacturing areas

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-SG

#LI-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.

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