Senior Consultant, GxPAssure
Senior Consultant, GxPAssure
Colleen Hoyt is a dynamic, technically strong, strategic leader with over 35 years of FDA experience across biological and pharmaceutical inspection operations, regulatory compliance, and end-to-end quality assurance. She has a proven track record in directing complex programmes, leading high-performing multidisciplinary inspection teams, and optimising operational performance in highly regulated environments.
She is a multiple-time recipient of the FDA Commissioner’s Special Citation, recognised for leadership in critical public health emergency responses—including Zika virus, H1N1 influenza pandemic, and necrotizing enterocolitis investigations.
Colleen has led major regulatory and compliance initiatives that improved pharmaceutical manufacturing standards, strengthened quality systems, and enhanced operational efficiency across inspectorates.
Colleen’s core competencies;