Robert Studholme

Background

About Robert Studholme

Project Manager experienced with quality systems management, business development, operations, engineering, and vendor management. Have direct experience with biopharmaceutical manufacturing, medical device development, design and manufacture of complex instrumentation. Expertise includes a detailed understanding of regulatory requirements, including FDA Quality Systems Regulations, cGMP Pharma Regulations, and ISO9001. A hands-on, results oriented project manager with a thorough understanding of budgets. Organization skills have been critical in the management of diverse project teams to meet corporate goals from business, operational, financial, technical, and quality perspectives. Critical, goal-oriented thinker with excellent communication and computer skills necessary to obtain buy-in for project plans across functional areas. Leadership, drive and fairness, coupled with high expectations for performance, have garnered respect from employees and co-workers. Demonstrated a unique ability to understand complex issues and provide innovative solutions.