Global Quality Auditor
About The Position
The Global Quality Auditor ensures that Sanofi Quality and Compliance Standards and applicable regulatory requirements are met. Through independent auditing and follow-up, the role supports Sanofi sites, Operational Units, affiliates, and third parties in achieving, maintaining, and improving compliance. The auditor leverages data, technology, and diverse expertise to support compliance through audits, inspections, regulatory surveillance, and advocacy. The position covers commercial activities and cGMP and GDP requirements across Sanofi’s product portfolio and global organizations, as well as external parties such as alliance partners, contract manufacturing organizations, and strategic vendors. Its international scope includes major regulators such as the US FDA, EMA, ANSM, NMPA, PMDA, and ANVISA. The role has no direct reports but may lead cross-functional initiatives or projects. It operates with a high degree of independence and can help shape Sanofi’s audit and inspection strategy by identifying emerging trends.
Requirements
- Bachelor’s degree in a relevant field, such as life sciences, pharmacy, or engineering.
- At least 5 years of experience in quality auditing, preferably in the pharmaceutical or biopharmaceutical industry.
- Fluent written and spoken English.
- Willingness and ability to travel domestically and internationally, approximately 50% on average.
- Strong written and verbal communication skills to convey complex compliance matters clearly to diverse audiences, including site teams and senior leadership.
- Strong analytical and problem-solving capabilities, including ability to detect trends and use data and metrics to assess quality system effectiveness against governing requirements.
- Ability to work independently and demonstrate a strong compliance mindset.
Nice To Haves
- Advanced degree such as an MSc, PharmD, or PhD.
- 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.
- Demonstrated leadership capabilities and cross-functional collaboration skills.
- For Europe-based roles, French-speaking ability is preferred.
- Ability to think creatively while taking thoughtful, calculated risks.
Responsibilities
- Act as a lead auditor or co-auditor in accordance with Sanofi processes.
- Support the 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 by developing targeted risk-based agendas and/or advising on mitigations.
- Escalate critical issues and risks.
- Approve and manage CAPAs.
- Participate in Quality Governance Committees, such as IRISC, as needed.
- Participate in audits and activities with other Sanofi Quality Audit, Inspection, Intelligence & Advocacy teams as needed.
- Contribute, as appropriate, to departmental QMS materials such as training curricula, standard audit agendas, and controlled documents.
- Lead cross-functional teams for initiatives or projects as needed.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Rewards package that recognizes employee contributions.
- Opportunities for career growth through promotion or lateral moves, domestically or internationally.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
