A working leader with global API / Biopharmaceutical leadership in project management, process and product development - transfer, manufacturing operations and quality assurance. Proven tracking record of managing engineering, maintenance, calibration, global technical, manufacturing, Quality, and contract operations. Demonstrated ability to provide leadership and direction across diverse organizations for maximum organizational output and performance. Solutions-oriented thinker able to create original, high-impact responses to complex pharmaceutical, medical device, and biologic processes; adept at identifying and resolving core issues, building cross-functional cohesiveness in multinational settings and delivering profitable results. In-depth knowledge of global cGMP regulations and success in forging relationships, teams, recruitment and staff development. As a skilled leader with a proven track record in the management of technical organizations with qualifications that include the successful completion or participation in major domestic and international projects, leadership and technical support of CapEx ranging from less than $1 Million to over $1.8 Billion. My comprehensive background in Project, Process and Plant Engineering comes with experience in troubleshooting, utilities, Environmental Health and Safety. I am recognized for bottom-line project management, cross functional team planning that includes Quality and Regulatory requirements, and product process transfer skills, program forecasting, risk analysis,. Disaster Recovery, Long range planning and short term readiness preparedness, Training content and Curricula development for diverse disciplines, business applications development and testing. Specialties include: Process, Automation, Facilities, Utilities, Systems, and Equipment design and execution. User Requirement Specifications, CAPA, Deviation, Validation and Quality documentation.