Senior Manager, Global Development Quality Assurance (GCP)
Regeneron
June 30, 2026
Remote
United States
Clinical Research and Development
Discover Your Role
- Manage, hire, and develop direct reports (monthly 1:1s, performance assessments).
- Provide training, resourcing, and individual staff development.
- Schedule, prepare, conduct, report, and follow up on routine and directed GxP audits per SOPs and quality policies.
- Conduct internal and external audits globally.
- Provide audit/compliance input in cross-functional meetings.
- Identify internal quality/compliance issues and drive process improvements for standardization and best practices.
- Interpret and help develop policies/standards; evaluate critical issues not covered by existing guidance.
- Provide education/training to GDQA and other Global Development departments.
- May participate in regulatory inspections as part of the control/inspection room team.
This Role Requires
- Bachelor’s degree (Master’s preferred); 8+ years relevant industry experience.
- Deep knowledge of FDA/EU regulations and ICH guidance affecting drug development and/or post-authorization safety monitoring.
- 5+ years direct people management and GCP audit experience (preferred).
- Excellent communication and people management; ability to work across all organizational levels and externally.
- Experience with FDA (or other) regulatory inspections of investigator sites, sponsors, or CROs.
- Strong leadership, problem-solving, written/verbal communication, project/partner management, collaboration, and negotiation.
Application Instructions
- Apply now.
- Manage, hire, and develop direct reports (monthly 1:1s, performance assessments).
- Provide training, resourcing, and individual staff development.
- Schedule, prepare, conduct, report, and follow up on routine and directed GxP audits per SOPs and quality policies.
- Conduct internal and external audits globally.
- Provide audit/compliance input in cross-functional meetings.
- Identify internal quality/compliance issues and drive process improvements for standardization and best practices.
- Interpret and help develop policies/standards; evaluate critical issues not covered by existing guidance.
- Provide education/training to GDQA and other Global Development departments.
- May participate in regulatory inspections as part of the control/inspection room team.
This Role Requires
- Bachelor’s degree (Master’s preferred); 8+ years relevant industry experience.
- Deep knowledge of FDA/EU regulations and ICH guidance affecting drug development and/or post-authorization safety monitoring.
- 5+ years direct people management and GCP audit experience (preferred).
- Excellent communication and people management; ability to work across all organizational levels and externally.
- Experience with FDA (or other) regulatory inspections of investigator sites, sponsors, or CROs.
- Strong leadership, problem-solving, written/verbal communication, project/partner management, collaboration, and negotiation.
Application Instructions
- Apply now.