Covers all GXP audit in areas of current, Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP).
Acts as a lead auditor or co-auditor, in accordance with Sanofi processes.
Conducts transversal assessments.
Contributes to team scheduling and reviews/approves audit reports for team members.
Evaluates entity risks developing targeted risk-based agendas and/or advise on mitigations.
Escalates critical issues and risks.
Approves / manages CAPAs.
Performs due diligence assessments, as/when needed.
Participates in audits and activities with other teams in Sanofi Quality Audit, Inspection, Intelligence & Advocacy.
May contribute to the creation of departmental QMS such as Training Curriculum, standard audit agendas, and controlled documents.
Latitude of action: Highly independent, creative with thoughtful risk taking and compliance mindset.
Role impact: Able to detect evolving trends which will result in adjustment of Sanofi audit and inspection strategy and tactics. Plays a key role in transforming the practice of auditing in Sanofi.
Scope: Global Quality organizations in Sanofi, country organization, and third parties outside of Sanofi (e.g. Strategic Vendors, etc.)
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the .
