Teams at Regeneron

Leads risk-based quality management across global clinical trials, including quality risk assessments, control tracking, issue management, CAPA, trend analysis, inspection readiness, and audit responses. Partners with study teams, monitoring groups, and contract research organizations to manage site risks and escalate significant quality events. Also oversees team onboarding, coaching, performance discussions, and administration.

Leads risk-based Good Clinical Practice audits across internal and external global activities, including scheduling, execution, reporting, and follow-up. Develops audit programs, identifies compliance issues, drives process improvements, supports regulatory inspections, and represents Quality Assurance on complex initiatives. The role requires strong knowledge of FDA, EU, ICH, and GCP requirements, stakeholder leadership, and willingness to travel domestically and internationally.

Supports Global Development quality system governance, quality event oversight, metrics and trend reporting, root cause investigations, CAPA development, procedural reviews, and continuous improvement. The role collaborates with quality stakeholders, facilitates governance meetings, presents quality system data, supports regulatory inspections, delivers training, and provides subject matter expertise in GCP and GVP quality management.