Seasoned Quality Systems and Auditing professional with forty-six years of experience in Ointments, Creams, Liquids, Solid Dose, Steriles, and API’s in small, medium and large, multi-site, multinational biotech, pharmaceutical and medical device companies, as well as start-ups. Advised multinational pharmaceutical companies on a variety of compliance issues during FDA inspections. Conceived, formed and executed numerous Quality-related agendas leading teams, both Quality and cross-functional, through successful conclusions. Has built Quality systems from the ground up. Was on the Lean Six Sigma team that reviewed the entire manufacturing process for two solid dose and one sterile/non-sterile liquid products facilities. Worked for Burroughs Wellcome, GlaxoWellcome, and Catalytica (all at the same site) from 1974-2000. From 2000-2019, consulted for Pfizer, GSK, Novartis, Bayer, Roche, Genentech, Cardinal Health, Apotex, Hill Dermaceuticals, Entegrion, Blue Marble Biomaterials, Blu, and many other smaller biopharmaceutical and medical device firms.