Global Quality CHC - Auditor - Europe

Sanofi

Budapest, Hungary

About the Role

As a Global Quality CHC Auditor, you will play a critical role in ensuring that our sites, development centers, suppliers, and partners meet the highest quality standards. You will be part of the CHC Audits and Inspections team, conducting GxP audits across Europe, and working collaboratively with global teams to uphold compliance with regulatory requirements and Sanofi’s quality policies.

Key Responsibilities

Conduct GxP Audits: Perform audits of CHC sites, development centers, suppliers, and partners, primarily across Europe, ensuring adherence to Sanofi/Opella quality policies and regulations.
Global Transversal Audits: Lead comprehensive assessments across multiple regions and teams.
Audit Preparation & Reporting: Prepare, conduct, and issue timely audit reports with actionable insights.
CAPA Management: Approve and oversee the timely implementation of corrective and preventive actions (CAPAs).
Regulatory Inspection Support: Assist in preparing for and following up on regulatory inspections within Europe.
Expert Guidance: Provide expertise on GxP requirements to regional entities, supporting both local and global teams.
Training & Certification: Contribute to the training and certification of new auditors within the region, enhancing their skillsets and knowledge.

What You’ll Bring

Experience: 10+ years in quality management and auditing in the pharmaceutical industry, with at least 5 years in a GMP/GDP environment.
Technical Expertise: Deep knowledge of GxP regulations, with experience auditing CHC drug products, nutraceuticals, cosmetics, and medical devices.
Leadership: Strong organizational, leadership, and communication skills, with the ability to make sound quality assessments based on diverse data sources.
Education: Advanced degree in life sciences or related fields (Pharmacist, Master’s, or PhD).
Languages: Fluency in English is essential; proficiency in French is a plus.

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