Scott Thatcher

Senior Consultant, GxPAssure

Scott R. Thatcher is an executive‑level pharmaceutical scientist and leader with more than 25 years of end‑to‑end pharma/biopharma experience across development, manufacturing, regulatory affairs, and quality leadership. He has contributed to over 50 corporate development programmes, achieved nine (9) NDA approvals from fifty-two (52) submissions, and led multiple successful technology transfers and FDA interactions, including in‑room audit participation, warning letter, and consent decree reconciliation.

Known and respected for his deep CMC, analytical, and process understanding, Scott has delivered robust control strategies, method validation programmes, risk assessments, and lifecycle management for a wide spectrum of delivery systems—from solid oral to injectables, inhalation systems, and drug‑device combinations. He is also a skilled Quality and QMS leader, having developed full GxP‑compliant systems from inception, overseen deviation/OOS/OOT/change management, and governed specification, method, and validation frameworks at CDMOs and partner sites.

Scott brings extensive vendor, CDMO, and supply‑chain oversight experience, including 30+ RFI/RFP processes, governance frameworks, KPI systems, and multi‑site technical leadership across API/Drug Product manufacturing, packaging, analytical services, and solid-state analysis. His portfolio includes contributions to numerous marketed products such as Gemzar®, Seromycin®, TobroDex®, Xigris®, Cialis®, Humulin®, and LoteMax®.

A recognised and published industry SME, Scott regularly delivers compliance training and serves as a USP Review Panel Expert.