Manager-Quality Assurance Auditor- GCP
About the role
Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager, GCP Auditing to join our Global Development Quality Assurance (GDQA) team, supporting clinical development activities across our global portfolio. You will build strategic partnerships leading risk-based quality audits across investigator sites, service providers, and internal processes, ensuring our clinical studies meet the highest standards of GCP compliance, while collaborating with study teams, cross-functional partners, and regulatory colleagues around the world. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Responsibilities
- Own the end-to-end audit process scheduling, preparing, conducting, reporting, and following up on routine and directed audits
- Lead a range of audit types across sites, vendors, license partners, and internal processes globally
- Apply deep knowledge of FDA, EU, and ICH regulations to independently resolve a variety of GCP compliance issues
- Represent GDQA on cross-functional teams and complex compliance projects spanning multiple departments
- Interpret regulations and quality standards, evaluating critical issues that fall outside existing guidance
- Support clinical study teams by developing and implementing risk-based audit strategies
- Step into regulatory inspections as part of the control or inspection room team when needed