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COMPLETE Head of Global Quality Audit and External Liaison - Cambridge

10 days ago


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Job Opportunity Details

Type

Full Time

Salary

Not Telling

Work from home

No

Weekly Working Hours

Not Telling

Positions

Not Telling

Working Location

Cambridge, Massachusetts, United States   [ View map ]

About the Job:

Our Team:

In GQA, it is our mission to define the Sanofi Global Quality Audit process and to coordinate its implementation across the group. We are committed to provide an accurate, independent assessment of Sanofi M&S / R&D sites, country offices and key third parties for compliance with Sanofi Quality Policy requirements and applicable regulations through constructive audit and inspection support activities.

We lead the external liaison group and manage our external relations to contribute positively to the development of regulations, guidance, policies, and initiatives that are external and relevant to Sanofi.

We are change leaders that challenge the current processes against external benchmark and industry trends, to target the best-in-class audit process and organization.

Main responsibilities:

  • Leadership of the Global Quality Audit team.

  • Provides direction and support for the GQA team for Sanofi site regulatory inspections

  • Ensures close interaction with the Chief Quality Officer and Global Quality Senior Leadership team to ensure good governance of the GQA activities, audit findings and related CAPA.

  • Interacts with Sanofi Internal Audit and Internal Control to identify and implement audit approaches that provide synergies and benefit to Sanofi.

  • Implements Risk based approached and drives the transformation within GQ-Change management mind set role modelling play to win behaviours

About You:

  • Experience: FDA & external liaison advocacy expert

  • Soft skills: risk-based decision making, relationship management, change management, transformation mind-set, empowering teams and leading by influence

  • Technical skills: Regulations and golden standard auditing practices

  • Languages: Fluent in English, French is a plus

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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Application Details

  • Organization Details
    (5100) Genzyme Corporation
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