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.
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.
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:
- 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
- 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
- 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
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.