Job Title: Global Quality Auditor
- Location:Remote within US
Main Responsibilities- 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.)
About YouBasic Qualifications:
- BS or BA degree in Pharmacy, Life Sciences, Engineering, or related, but will consider all degrees.
- Minimum 5+ years of extensive experience in GxP domains, Good Pharmacovigilance Practices, or Good Clinical Practices.
Preferred Qualifications:
- Deep knowledge of global regulatory requirements and standards.
- Strong understanding of quality management systems (QMS).
- Leadership Skills: Ability to lead cross-functional teams and initiatives
- Risk Assessment: Expertise in evaluating and mitigating quality risks
- Communication: Excellent written and verbal communication skills
- Independence: Highly independent with creative problem-solving abilities
- Compliance Mindset: Strong ethical foundation with thoughtful risk-taking approach
- Adaptability: Ability to detect evolving trends and adjust strategies accordingly
The salary range for this position is:
$133,500.00 - $192,833.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
