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Quality Auditor Senior-Ridgefield, NJ

Ridgefield, New Jersey

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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

COMPANY DESCRIPTION

Sanofi has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through excellent research, collaboration with the global patient community, and with the compassion and commitment of our employees.  With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve.  Sanofi-Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients.

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, animal health and the new Genzyme.

Genzyme Corporation (a Sanofi company) 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, religion, sex, national origin, disability or protected veteran status, or any other characteristics protected by applicable law.

JOB DESCRIPTION – Senior Auditor, Quality

Monday - Friday First Shift with occasional overtime

Work with suppliers and act as the liaison between the Procurement Department and QA to ensure suppliers/vendors continue to deliver quality products and services to the facility. This responsibility will be realized through participation in the Supplier Management Team, performing supplier/vendor audits, maintaining the supplier corrective action program, and interaction with the individual supplier/vendor as appropriate. 

Plan, perform, and oversee the auditing process that includes timely completion of tasks in Phenix.

Auditing of suppliers/vendors may involve an overnight stay and abroad travel as required

(Approximately 20% travel)

Document supplier audit results in written audit reports that are distributed and reviewed by appropriate management.

Assures that the Supplier/Vendor Quality System audit function complies with QSR/GMP, ISO, and all applicable regulatory requirements.

Review and evaluate audit responses against current standards, regulations, and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance, and continuing efficacy.

Assist in maintaining the Supplier Qualification Program for existing and new suppliers/vendors.

Managed professional relationship with suppliers/vendors to ensure their adherence to quality standards and facilitate environment of continual improvement.

Must be able to undergo and successfully complete the Sanofi Lead Auditor Certification process

The Incumbent will ideally have some Project Management experience and will be capable of implementing projects, initiatives, and improvements either as an individual contributor or as part of a team.

Performance of trending and metric generation will be required as part of this role to ensure compliance and provide confidence that the relevant quality systems are operating in control.

This position works closely with Manufacturing Operations, QA Management, Procurement and Suppliers, and Service Providers. The role will be expected to provide advice and support in the resolution of compliance-related concerns and initiatives and apply their own professional knowledge to identify areas of risk to compliance with GMP’s proactively.

Will be responsible for authoring, reviewing, and approving GMP documentation and may be responsible for developing and delivering training related to supplier management topics.

Will be assisting in authoring, revising, and maintaining QTA’s between vendors and service providers, and liaison with respective parties such as Procurement and Legal.

Manage assigned projects.

Basic Qualifications

  • Bachelor’s degree in Engineering or Science discipline 
  • Minimum 4 years of pharmaceutical industry experience
  • Minimum 4 years of auditing experience
  • In-depth understanding of auditing and control practices.

Preferred Qualifications

  • Extensive Supplier Management experience,
  • Proven ability to conduct and manage audits.
  • Strong understanding in FDA CFR Parts 11, 210, 211, and 820, ISO 13485, 9001 and/or other applicable regulations.
  • Strong knowledge of quality and compliance in a regulated GxP/QMS environment.
  • Handling SCNs, SCARs managing ASL and QTAs, usage of Athena and Phenix.
  • Very good communicator, writing and organizational skills.
  • Ability to work across functions.
  • Ability to multi-task multiple projects.
  • Adaptable to change.
  • Ability to work in a team as well and individually.
  • Ability to draw on past experiences to influence future outcomes.
  • Ability to research information for problem resolution to projects.

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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