Manager, Quality Assurance Compliance

Regeneron Pharmaceuticals•Rensselaer, NY

7d•$92,200 - $176,000•Onsite

About The Position

Regeneron is currently seeking a Manager Quality compliance to join our Quality Assurance team. This position is responsible for managing the compliance, audit, training and operations team for the internal fill finish site. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

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

Nice To Haves

Experience with drug product manufacturing and/or fill finish is preferred

Responsibilities

Lead and develop the QA compliance team: set work plans and objectives, prioritize and assign tasks, coach performance, and manage hiring and separations while aligning deliverables with company goals
Partner with Managers and Directors to communicate compliance status, audit readiness, and training initiatives, and 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, and support internal and regulatory audits, including coordinating requests for the internal fill-finish team
Promote cross-site continuous improvement by collaboratively 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