Thirteen years experience in medical devices, with both hands-on Production and Quality Assurance positions managing various Quality Systems. Additional ten years of Quality experience in the pharmaceutical industry; six years facilitating GxP audits and four as Associate Director of Quality Operations and GMP Compliance at a sterile aseptic fill pharmaceutical site.Over seven years experience as an independent consultant with multiple clients. The clients ranged from Pharmaceutical, Medical Device, Laboratory, and IVD entities.Experience ranged from regulatory inspection preparedness ( e.g. FDA, AATB), building Quality Systems, conducting audits across the client's entire supply chain., and serving as Interim Head of Quality.
Listed skills include Pharmaceutical Industry, Quality Auditing, Glp, 21 Cfr Part 11, and 19 others.