Strategic International Quality/Regulatory/Medical Affairs Executive with over 30 years of proven leadership experience and a track record of achieving outstanding results within large multi-national corporations. Effectively driven progressive yet business oriented quality programs through the development and retention of high caliber teams. A common sense, data driven approach coupled with an extraordinary ability to assess and achieve global performance by creating metrics and measures that drive the right behaviors resulting in strong quality culture at all levels of the organization.Key attributes:• Organizational Strategy and Vision• Business Acuity• International Experience• Building and Developing High Performance Teams• Relationship Building (Internal and External)• Regulatory Intelligence• Practical Application of Regulation• Change Agent/Enabler• Balanced Risk ManagementProduct Breadth: Medical Devices, Pharmaceuticals, and BiologicsSpecialties: Quality Assurance, Regulatory Affairs, Medical Devices, Pharmaceutics, Biologics, Quality Systems Architecture & Design
Listed skills include Fda, Quality System, Medical Devices, Iso 13485, and 26 others.