Teams at Regeneron

Leads risk-based Good Clinical Practice audits across internal teams, clinical sites, vendors, partners, and other global activities. Responsibilities include audit planning, execution, reporting, follow-up, compliance issue resolution, process improvement, regulatory inspection support, and quality initiatives. The role requires expert knowledge of GCP regulations, independent management of complex compliance matters, senior stakeholder engagement, and 30–40% domestic and international travel.

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.

Lead risk-based GCP audit strategy and planning across therapeutic areas, manage audit outcomes and trends, represent QA on cross-functional initiatives, deliver reports/metrics to leadership, and collaborate with global stakeholders. Requires navigation of ambiguity and prioritization of complex activities.