Senior Consultant, GxPAssure
Senior Consultant, GxPAssure
Collen F Hoyt is a dynamic, technically strong leader with over 35 years of experience across biological and pharmaceutical operations, regulatory compliance, and end‑to‑end quality assurance. Proven track record in directing complex programmes, leading high‑performing multidisciplinary 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 global sites.
Colleens core competencies;