Senior Manager GCP Quality

Role: Senior Manager, GCP Quality Management, supporting global clinical development within Regeneron’s fast-growing organization. Responsibilities: lead risk-based quality management across assigned trials, conduct protocol-stage Quality Risk Assessments per ICH E6 R3, manage quality issues, audit responses, CAPAs, and trends; partner with study teams, CROs, and internal quality functions; support inspection readiness and regulatory responses; oversee team onboarding, development, coaching, and performance management. Requirements: Bachelor's degree; 8+ years in healthcare or pharma, with expertise in quality, compliance, clinical development, GCP, or PV; advanced risk management, audit, and inspection experience; proven leadership, process improvement, and project management skills; strong communication and collaboration abilities; proficiency in Microsoft Office. HighValue: clinical trial quality oversight, risk management, GCP compliance, inspection readiness, global development support, hybrid work location, no specific therapeutic focus but applicable across clinical trials.