Qualifications Director of Operations responsible for manufacturing products in accordance to specifications, regulatory requirements in high volume/capacity production plants. Directly reported to founder of company and Board of Directors. Senior Clinical Project Manager with 5+years' experience in running medium to large scale complex projects for R&D, Manufacturing of medical compounded products, and processes related to compliant delivery to patient. (Focus on Oral Dosage and Topical Ointments) Information Technology Project Manager experienced and accomplished at developing scope, execution, implementation, control/monitoring and completion of specific projects on time and on budget according to systems development lifecycle. Continuous Improvement/Six Sigma Green Belt with "Voice of the Customer" process improvement experience. Designed and completed process reengineering projects which resulted in savings to resources and cost. Selected Accomplishments * Quality Management Review (QMR) and Metrics Program. Designed and implemented quarterly report to inform senior leadership of issues concerning product manufacturing, vendor/ supplier performance, and the reliability of the quality management system. Quality Information Systems - Created enterprise level databases to effectively store and categorize large amounts of information related to manufacture of biological & pharmaceutical made products. Automated manual processes and created measurable productivity across work streams. * * Instructional Training Documentation - Created standard operating procedures and its complementary training modules to standardize work instructions. Documented training and program within company framework and increased staff productivity. Successfully managed a cross-functional manufacturing department staff dedicated to achieving company goals, with respect to budget and financial constraints. Achieved goals and increased revenues by 30% within an operating budget of less than $2 million. * Accomplishments * Quality Management Review (QMR) and Metrics Program. Designed and implemented quarterly report to inform senior leadership of issues concerning product manufacturing, vendor/ supplier performance, and the reliability of the quality management system. Quality Information Systems - Created enterprise level databases to effectively store and categorize large amounts of information related to manufacture of biological & pharmaceutical made products. Automated manual processes and created measurable productivity across work streams. * * Instructional Training Documentation - Created standard operating procedures and its complementary training modules to standardize work instructions. Documented training and program within company framework and increased staff productivity. Successfully managed a cross-functional manufacturing department staff dedicated to achieving company goals, with respect to budget and financial constraints. Achieved goals and increased revenues by 30% within an operating budget of less than $2 million. *

Highlights:

• six sigma
• compliance
• cgmp
• Document Management
• Quality Control
• Stability
• CMOS
• Enterprise Resource Planning
• Management
• Management Review