Todd Mabe

Merck & Co., Inc.

Todd Mabe is the Executive Director Global Quality Disposition for development quality where he leads the disposition of Merck small and large molecule drug Substance and Drug product Clinical phase I, II, III and commercial qualification products. His oversight includes the disposition of internal and external manufactured clinical goods. His team ensures that quality expectations are met for establishing clinical specifications, clinical protocols, deviation management, change management, lot release, CAPA, risk management, regulatory filings and inspections. He is a member of the leadership team that develops and executes the Merck future clinical strategy.

Prior to this role, he was involved in commercial Drug Substance Strategy setting for Merck, led the Biologic External Quality Drug Substance group for Roche/Genentech and was the Quality Lead for Quality, Engineering & Validation efforts for two new Roche bulk API (E-coli and CHO) facilities in Singapore. His efforts helped Roche receive the 2010 "Facility of the Year Award" in Singapore. He was a Validation Quality Manager in Corporate Quality Systems & Support for Genentech supporting the development and establishment of validation policies/standards and quality system process improvements.

His past experiences in the biotech and pharmaceutical industries include QC release testing and quality management. He has been a validation manager and a quality consultant. He has experience in establishing and maintaining quality systems for validation, document management, change control, discrepancy management, training, validation document strategic development, execution and approval; analytical method validation; and the engineering of pharma and biotech facilities