*30 years of international experience in clinical, contract, and commercial manufacturing, primarily in leadership roles*Achieved broad commercial experience in small molecule, large molecule, biologic, gene therapy, and medical device manufacturing*Directed multiple facilities and department operations, with groups as large as 800+ employees to support clinical and commercial manufacturing activities in a cGMP/GLP environment*Experienced in satisfying the compendial quality systems, resolving enforcement actions, and other global regulatory requirements for pharmaceutical and medical devices in global regulatory environments*Drove Quality input and oversight during the initial public offering conversion of private company*Successfully lead the remediation by working with FDA on lifting a warning letter and restoring routine manufacturing operations quality in multiple locationsAchieved centralizing, structuring, and leading a strong global quality organization of 300+ employees at six locations worldwide*Built and sustained positive and constructive organization of over two hundred client relationships while creating solutions for the benefit of the client and the Company*My goal is to partner with operations stakeholders to deliver support in a predictable way with the proper sense of urgency. I have a solid track record for developing lab operations and personnel. *The opportunity to work on cross-functional projects within the organization is important to me. I enjoy leading or working in a team using the training I received in project and risk management tools for problem solving across departments or sites.