Ralph is an accomplished global Pharmaceutical Quality, Manufacturing/Supply, Product Development, and Regulatory Compliance thought leader with a track record of successfully organizing and executing major strategic initiatives with corporate-level impact.
He has broad global and domestic experience across pharmaceutical manufacturing and development as a practitioner and hands-on leader.
Ralph holds a PhD in Pharmaceutics, MS in Management Science and Engineering, and a BS in Chemistry. He is a Certified Lean Sigma Green Belt.
Ralph has been an invited lecturer for Japanese MHW Inspector training and Pharma China SFDA training. He lectures on Supply Chain Management and Security at Villanova University.
He has extensive interaction with the US FDA and with regulatory agencies worldwide including pre-approval and for-cause inspections and response to inspectional observations and actions including Warning Letters and Consent Decree.
He has held a number of senior positions in the industry, including Head, Corporate Integrity Program Office, Vice President Technical and Analytical Sciences; Vice President Quality Center of Excellence; Vice President Strategic Manufacturing Alliances & Procurement; Vice President Worldwide Regulatory Compliance, Director, Pharmaceutical Technologies; Manager Chemical and Pharmaceutical Production.
Examples of projects completed: