Client-focused pharmaceutical executive with over 30 years’ experience as a leader in quality system development. Master regulatory compliance problem solver – small and large molecules / early phase through commercial. Extensive experience in supplier selection and approval; coordination of strategic plans to prepare manufacturing sites for critical inspections; and direct interface with FDA, EMA and other regulatory bodies.• GMP oversight of new facility design • Quality management of tech transfer• Onsite contract manufacturing support • Regulatory inspection hosting
Listed skills include Quality Systems Expert, Cmo Selection And Management, Team Leader Advocate For Continuous Process Improvement, Start Up Specialist, and 28 others.