Manager-Quality Assurance Auditor- GCP
Regeneron
August 10, 2026
Remote
United States
Clinical Research and Development
Discover Your Role:
- 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 GCP compliance issues.
- Represent GDQA on cross-functional teams and complex compliance projects spanning multiple departments.
- Interpret regulations and quality standards; evaluate critical issues outside existing guidance.
- Support clinical study teams by developing and implementing risk-based audit strategies.
- Participate in regulatory inspections as part of the control/inspection room team when needed.
- Mentor and help onboard new GDQA staff.
This Role Requires:
- Bachelor’s degree with 6+ years of relevant industry experience, including 4+ years of direct GCP audit experience; experience supporting risk-based audit strategy development for clinical studies.
- Experience applying FDA and EU regulations, including ICH E6 R3 and applicable standards.
- Ability to manage multiple complex priorities and make complex decisions with urgency.
- Strong project management, stakeholder management, collaboration, and negotiation skills.
Application:
- Apply now.
- 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 GCP compliance issues.
- Represent GDQA on cross-functional teams and complex compliance projects spanning multiple departments.
- Interpret regulations and quality standards; evaluate critical issues outside existing guidance.
- Support clinical study teams by developing and implementing risk-based audit strategies.
- Participate in regulatory inspections as part of the control/inspection room team when needed.
- Mentor and help onboard new GDQA staff.
This Role Requires:
- Bachelor’s degree with 6+ years of relevant industry experience, including 4+ years of direct GCP audit experience; experience supporting risk-based audit strategy development for clinical studies.
- Experience applying FDA and EU regulations, including ICH E6 R3 and applicable standards.
- Ability to manage multiple complex priorities and make complex decisions with urgency.
- Strong project management, stakeholder management, collaboration, and negotiation skills.
Application:
- Apply now.