Global Quality Auditor

Sanofi

. Ensure Sanofi Quality and Compliance Standards and applicable regulatory requirements are met .

Posted 10/17/2026full-timeRemote • United StatesMid-LevelSenior💰 $133,500 - $192,833 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in quality auditing and compliance within the pharmaceutical industry, with a strong focus on regulatory requirements, risk assessment, and CAPA management. Capable of leading cross-functional teams and adapting audit strategies based on evolving trends and data analysis.

Highest-signal resume keywords

Quality AuditingRegulatory Inspection SupportCAPA ManagementRisk Assessment FrameworksCGMP Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality Management System (QMS)Audit MethodologiesRisk-Based Audit MethodologiesRegulatory RequirementsInternational Regulatory KnowledgeData AnalysisTrend DetectionCAPA Approval and ManagementTransversal AssessmentsLeadership in Auditing

Soft Skills

Strong Compliance MindsetCreative Problem SolvingCross-Functional CollaborationExcellent Communication SkillsSelf-Directed Work Ethic

Industry Keywords

Pharmaceutical IndustryBiopharma IndustryUS FDAEMAANSMNMPAPMDAANVISAQuality Governance CommitteesManufacturing & Supply

About the role

Key responsibilities & impact

Ensure Sanofi Quality and Compliance Standards and applicable regulatory requirements are met
Conduct independent audits and follow up on findings
Act as lead auditor or co-auditor in accordance with Sanofi processes
Support qualification of new auditors
Conduct transversal assessments
Prepare, coach, and support entities for regulatory inspections, including unannounced or short-notice visits
Participate in external associations to stay current with emerging trends
Evaluate entity risks through targeted risk-based agendas and mitigation advice
Escalate critical issues and risks
Approve and manage CAPAs
Participate in Quality Governance Committees such as IRISC
Participate in audits and activities with Sanofi Quality Audit, Inspection, Intelligence & Advocacy teams
Contribute to departmental QMS, including training curricula, standard audit agendas, and controlled documents
Lead cross-functional teams for initiatives or projects as needed
Detect evolving trends and help adjust Sanofi audit and inspection strategy and tactics
Transform auditing practices across Sanofi
Cover Manufacturing & Supply, Research & Development, Country Offices, Digital, Global Quality organizations, and third parties

Requirements

What you’ll need

Bachelor’s degree in life sciences, pharmacy, engineering, or any field
5+ years' experience in quality auditing, preferably within the pharmaceutical or biopharma industry
Strong track record in cGMP environments, regulatory inspection support, and risk-based audit methodologies
In-depth knowledge of international regulatory requirements and major health authorities including US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA
Proficiency in audit methodologies, CAPA management, and risk assessment frameworks
Highly independent and self-directed, with a strong compliance mindset
Ability to think creatively while taking thoughtful, calculated risks
Demonstrated leadership capabilities and cross-functional collaboration skills
Willingness and ability to travel domestically and internationally, approximately 50%
Fluent written and spoken English
French-speaking preferred for Europe-based role
Excellent written and verbal communication skills
Strong analytical and problem-solving capabilities
Ability to detect evolving trends and leverage data and metrics to assess quality system effectiveness against governing requirements

Benefits

Comp & perks

Opportunities for promotion or lateral career moves, at home or internationally
Thoughtful rewards package
High-quality healthcare
Prevention and wellness programs
At least 14 weeks’ gender-neutral parental leave
Cutting-edge technology, digital, data, and AI-driven innovation opportunities