Manager, Quality Assurance Compliance
Regeneron
June 26, 2026
On-site
East Greenbush, NY
Operations
Location: Rensselaer, New York, United States (Monday–Friday, 8am–4:30pm)
Discover Your Role
- Lead and develop the QA compliance team: set work plans and objectives; prioritize and assign tasks; coach performance; manage hiring and separations; align deliverables with company goals.
- Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives; provide concise, actionable project reporting.
- Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure.
- Drive audit readiness and execution: align QA practices with requirements; run the audit-ready-365 program; plan and track coaching; support internal and regulatory audits, including coordinating requests for the internal fill-finish team.
- Promote cross-site continuous improvement by identifying gaps and sharing best practices.
- Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices.
- Stay current on industry trends and regulatory updates and translate insights into changes and improvements.
This Role Requires
- BS/BA in Life Sciences or related field; or equivalent combination of education and experience.
- Associate Manager Quality Compliance: 6+ years of relevant experience.
- Manager Quality Compliance: 7+ years of relevant experience.
- Preferred: Experience with drug product manufacturing and/or fill finish.
Application Instructions
- Apply now.
Discover Your Role
- Lead and develop the QA compliance team: set work plans and objectives; prioritize and assign tasks; coach performance; manage hiring and separations; align deliverables with company goals.
- Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives; provide concise, actionable project reporting.
- Oversee the lifecycle of quality records (Notices of Event, Change Controls, CAPAs): track, report, and drive timely closure.
- Drive audit readiness and execution: align QA practices with requirements; run the audit-ready-365 program; plan and track coaching; support internal and regulatory audits, including coordinating requests for the internal fill-finish team.
- Promote cross-site continuous improvement by identifying gaps and sharing best practices.
- Shape governance by influencing local and global policies, procedures, and business processes to align with industry standards and best practices.
- Stay current on industry trends and regulatory updates and translate insights into changes and improvements.
This Role Requires
- BS/BA in Life Sciences or related field; or equivalent combination of education and experience.
- Associate Manager Quality Compliance: 6+ years of relevant experience.
- Manager Quality Compliance: 7+ years of relevant experience.
- Preferred: Experience with drug product manufacturing and/or fill finish.
Application Instructions
- Apply now.