Accomplished Quality Assurance professional with over 30 years of experience in pharmaceutical research from both a sponsor and Contract Research Organization (CRO) perspective for a multi-national company. Extensive QA experience in all aspects of Clinical (GCP) and Preclinical (GLP) studies and experience with Manufacturing (GMP) Quality Assurance responsibilities in R&D solid-dose formulations. Recognized leadership in the preparation, coordination and follow-up of regulatory inspections by US FDA, Health Canada, EMEA and ANVISA along with sponsor study and site qualification audits.Specialties: Data integrity, GLP and GCP compliance, bioanalytical analysis, bioequivalence and bioavaivability studies, Phase I-IV, negotiation skills
Listed skills include Fda, Validation, Cro, Clinical Trials, and 29 others.