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Sanofi Group Global Quality Auditor M/F in Framingham, Massachusetts

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

Job overview:

The role ensures that Sanofi Quality and Compliance Standards and applicable government regulations are met, and that all Sanofi sites and third parties improve their current levels of compliance, through independent auditing and follow-up.

Responsibilities:

  • Conduct quality audits of GxP activities

  • Write audit reports and review and monitor Corrective and Preventive Action (CAPA) Plans and timelines

  • Develop and maintain audit related Global Quality Documents

  • Support regulatory inspections of Operational Quality Units

  • Actively communicate with and support Operational Quality Units

  • Support and participate in training efforts as requested by Operational Units or sites, including inspection preparation training and auditor certification training

Requirements & Qualifications:

Basic Qualifications:

  • Candidate must possess a Science Graduate degree or equivalent, with at least 10 years of relevant experience in the pharmaceutical industry or a major regulatory authority

Preferred qualifications:

  • Fluency in written and spoken English required; ability in French or other languages an advantage

Essential Technical Skills:

  • Strong technical background in quality, production, or regulation of biologics, vaccines, medical devices, combination products, or injectable medicinal products for human use with an in-depth knowledge of pharmaceutical operations

  • Advanced knowledge of GxP regulations applicable to cosmetics, nutraceutical, medicinal and medical device products for human use

  • Ability to identify gaps in GxP quality and compliance while auditing, clearly and comprehensively document them in writing, and present them to site personnel and upper management in a concise and easily understandable manner

  • Ability to appropriately assess the adequacy of proposed corrective and preventive actions and timelines for implementation

  • Ability to work efficiently and effectively both independently as well as with colleagues globally

  • Ability to resolve conflicts and disagreements in order to reach mutually agreeable resolutions to issues

  • Ability to influence others without having direct authority over them

Specific experience and knowledge:

  • Auditing or inspecting regulated healthcare sectors

  • Compliance and regulatory inspections, particularly US FDA and EMA GxP regulatory inspections

  • GxP regulations (e.g. ANSM, US FDA, EMA, WHO, MHRA)

  • Risk control and management

  • Continuous process improvement methodology

  • GxP Computer System requirements

Travel requirements:

  • This position requires approximately 50% travel that will include weekends and public holidays as the business requires

What makes this position unique?

This role provides the opportunity to work in the only internal global quality audit team in Sanofi, with an auditing scope that covers all GxP activities for all pharmaceutical dosage forms in the company. The position gives unrivalled opportunity to interact with many different Sanofi facilities and entities across the Sanofi global network.

Benefits of working in this role:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a culturally and technically diverse team of pharmaceutical regulatory compliance experts

  • Professional and personal development will be supported purposefully; developing skills and experience in not just auditing, but also all Sanofi GxP activities

  • Broad experience and skills that come from working in this role are highly transferrable for future career opportunities

Location information:

The role will be based in Gentilly France, Frankfurt Germany, or Bridgewater, New Jersey / Framingham, Massachusetts - USA

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.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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