Henry Piel
About Henry Piel
Henry Piel serves as the Head of Quality and Senior Director of Quality Assurance at Leap Therapeutics, where he leads GxP Quality Assurance and Quality Systems functions. He has extensive experience in quality management across various pharmaceutical companies and holds multiple degrees from Harvard Extension School.
Current Role at Leap Therapeutics
Henry Piel serves as the Head of Quality and Senior Director of Quality Assurance at Leap Therapeutics, a position he has held since 2021. In this role, he leads the Good Practice (GxP) Quality Assurance and Quality Systems functions for the company. His focus includes overseeing the quality systems for the lead candidate, DKN-01, which is currently in Phase 2 clinical trials for oncology indications. He has implemented an electronic document management system, ZenQMS, to enhance the quality systems within the organization.
Previous Experience in Quality Assurance
Henry Piel has extensive experience in quality assurance across various pharmaceutical companies. He worked at Takeda as Associate Director of Clinical Quality Assurance for 10 months in 2016-2017. He held multiple positions at FORUM Pharmaceuticals, including Senior Manager and Associate Director of Quality Assurance, from 2013 to 2016. Additionally, he served as Executive Director of Clinical Quality Assurance at AMAG Pharmaceuticals in 2019 and 2020, and as Senior Director of Quality Assurance at Syndax Pharmaceuticals in 2019.
Education and Academic Background
Henry Piel studied at Harvard Extension School, where he concentrated in the History of Science and minored in Psychology, earning a Bachelor of Liberal Arts (ALB). He is also a candidate for a Master of Liberal Arts (ALM) with a concentration in History. Additionally, he holds an Associate of Arts (AAE) from Harvard Extension School. His foundational education includes a high school diploma from Marshfield High School.
Regulatory Knowledge and Compliance Initiatives
Henry Piel possesses a demonstrated working knowledge of multiple regulatory frameworks, including 21 CFR, ICH Guidelines, and ISO standards. At Leap Therapeutics, he developed a comprehensive General Data Protection Regulation (GDPR) program to ensure data protection compliance. His expertise encompasses managing quality systems for drug products, including biologics and synthetic molecules, across therapeutic areas such as oncology and women's health.
Military Service
Before his career in pharmaceuticals, Henry Piel served in the US Navy as a Radioman, Second Class Petty Officer (E-5) from 1984 to 1988. This experience contributed to his leadership and communication skills, which he has applied throughout his professional career in quality assurance.