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Date Created: 12/22/15
Deborah L. Ford, Ph.D. Bowie, MD 20715 (301) 352-7083 Forddeborah2@yahoo.com Summary: A project management professional with years of progressive and diverse experience in quality, management, and project management. A successful team builder with well developed communication and interpersonal skills. Exceptional track record of success in the following areas: FDA regulated industries, quality management, project budgets, problem resolution and successful project completions. Successful team leader with a proven record of finding solutions to diverse management and project issues. Career Highlights Medical Devices Healthcare IT Project Management Pharmaceutical/Biotech ECM Program Management 6-sigma Green Belt ISO 13485 / 9001 Trainer Experience: Consumer Healthcare Products Association, Washington DC (2011 to present) A not-for-profit association representing the makers of over-the-counter medicines and nutritional supplements, and the consumers who rely on these healthcare products Director, Project Management Developed, implemented, and managed the Project Management Office (PMO) Managed the development and tracking of all aspects of multimillion dollar programs and projects Responsible for program and project budgets and timelines Trained personnel on Project management methodology Provided Project Management and process improvement support to the association QPharma, Inc., Morristown, NJ (2008 to 2010) A privately owned consulting company specializing in FDA Regulatory and Compliance Solutions. Regional Manager Managed QPharma and contract personal located on various projects throughout Maryland and locations nationwide. Wrote and managed contracts and proposals. Responsible for program and project budgets and timelines Trained and mentored personnel FDA regulations Managed and prepared multimillion dollar budget for region Managed several projects simultaneously (program manager) (IT and non-IT) Managed software validation projects. Consulted with various companies on FDA regulations (Parts 210, 211, 820). Lectured at conferences on quality systems, including Enterprise Content Management systems. Qiagen / Digene Corporation, Gaithersburg, MD (2003 to 2008) A multimillion medical device corporation that develops, manufactures and markets proprietary DNA and RNA testing systems for the screening, monitoring and diagnosis of human diseases. Digene's primary focus is in women's cancers and infectious diseases. Senior Manager, Quality Systems Designed and successfully lead the implementation of the international corporate project plan for combining CFR Ford Resume 1 of 3 Parts 210, 211, and 820 with the ISO 13485 standard resulting in retaining international revenues of $20 million. Conducts audits against Parts 210, 211, and 820 Trained personnel on FDA compliance Managed the corporate documentation system in compliance with FDA regulations Managed the compliance and content of the multimillion dollar Enterprise Content Management system (part of system was for CRM) Lead projects to redesign and validate various components of the Enterprise Content Management system Lead the major portion of the project to redesign and validate the entire Enterprise Content Management system Lead the project to implement a new enterprise document management system in North America Developed and successfully implemented training on new and updated IT projects as part of project plan United States Postal Service, Washington, DC (2003 to 2003) A multi-billion dollar organization responsible for the timely pickup and delivery of U.S. mail. Operations Specialist, Processing Operations Work on projects to reduce cost and improve efficiency in mail processing plants. DesignTech, Springfield, VA (2002 to 2003) A privately owned company specializing in innovative home electronics Quality Manager Managed the quality department in compliance with ISO 9000 standards Fres-co Systems USA, Inc., Telford, PA (1999 to 2001) A $60 million leading supplier of flexible laminated materials and form & fill machinery for the coffee, agriculture, pet food, and specialty food markets. Department (Operations) Manager Full departmental responsibility for 70 associates including 4 supervisors. Implemented associates brainstorming session to address several key production issues ultimately improving production productivity by 11%, reducing turnover by 20% and saving the company in excess of $450,000 per year. Implemented training programs for new hires reducing employee frustrations, reducing workers compensation claims while improving reliability and enhancing the production process. Lead operations portion of project that created and installed a new Management Resources Planning (MRP) system streamlining the forecasting of manpower, raw materials, machine time and shipping. Providing better controls and improving quality and customer satisfaction. R J R Nabisco Corporation - Packaging Division, Winston-Salem, NC (1988 to 1999) A multibillion dollar world leader in the supply of snack foods and innovative flexible packaging for the medical device and pharmaceutical industries. Process Engineer / Quality Engineer Shift Supervisor Safety, Health, and Environmental Specialist Quality Assurance Supervisor Complete responsibility for customer satisfaction and product performance from product inception to product retirement. Lead project that developed, implemented, and maintained the cGMP process in compliance with Parts 210, 211, and 820. Resulting in 15% improvement in efficiency, quality awards, and no 483s. Ford Resume 2 of 3 Developed and modified Standard Operating Procedures. This resulted in a 20% increase in efficiency. Trained associates and management personnel on quality and cGMP (Parts 210, 211, and 820) compliance. Designed the training sessions and tailored the sessions to each group. This resulted in 20% improvement in quality. Lead the project that created a safety, health and environmental program for the facility. This program resulted in a million man-hours without a lost-time accident, which reduced worker’s compensation and lowered insurance premiums Developed and implemented the project for computer-aided manufacturing to completely automate the manufacturing equipment. Certifications: Project Management Professional (PMP) Certification 6-Sigma Green Belt Certification Education: Walden University, Minneapolis, MN Ph.D., Organizational Psychology (Change Management) University of North Carolina at Greensboro, Greensboro, NC Masters, Business Administration Cornell University, Ithaca, NY BA, Biochemistry Computer Skills Proficient in following computer software: Microsoft Office Suite, Microsoft Project, Microsoft Visio, Material Resource Planning Systems, Computer-aided manufacturing systems, Enterprise Content Management Systems Ford Resume 3 of 3
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