Senior Pharmaceutical Quality, Manufacturing/Supply, Product Development and Regulatory Compliance Consultant.
Ralph is a recognized thought leader in the areas of Pharmaceutical Quality, Manufacturing & Supply, Product Development, and Regulatory Compliance, with a long track record of successfully organizing and executing major strategic initiatives with corporate-level impact.
He earned his PhD in Pharmaceutics from Temple University and has over 45 years of broad global and domestic experience as both a practitioner and a hands-on leader. Ralph has extensive interaction with the US FDA and with regulatory agencies worldwide. He is an expert in successfully managing pre-approval and for-cause inspections and in responding to inspectional observations and actions.
Ralph began his career with Astra Pharmaceuticals and joined Smith, Kline and French Laboratories in Philadelphia in 1979. During his 37 years with SK&F (later GSK) he made significant contributions in the commissioning and operation of sterile manufacturing facilities and in the late stage development and commercialization of new products. He held a number of senior leadership positions including Head, GMS CIA Program Office; Vice President Technical and Analytical Sciences; Vice President Quality Center of Excellence; Head, Cidra Compliance Improvement Program; Vice President Worldwide Regulatory Compliance; and Director, Pharmaceutical Technologies.
Ralph enjoys working in multicultural settings and has considerable experience in Asia/Pacific, Europe and Latin America, including being an invited lecturer for Japanese MHW Inspector training and the Pharma Chinese SFDA training course. He also lectures on Supply Chain Management and Security at Villanova University. He is a Certified Lean Sigma Green Belt, and is a past member of the ISPE Board of Directors and International Leadership Forum. He resides in Cherry Hill, NJ.