Provide effective leadership and oversight for the overall deployment of the quality system in all areas of technical and clinical operation. This positions serves as a resource to operations on quality issues.

Improve operational efficiency through process improvement and the introduction of new technologies.

Provide quality and regulatory direction to a company operating in both the blood banking and cellular therapy industries. Improve efficiency of the quality assurance department. Develop expansion plans then monitor quality status of apheresis collection sites collecting human raw material for Provenge (Dendreon).

Manage deployment design and implementation of the American Red Cross (ARC) end-to-end computer system for blood center management. Project Lead for an ISBT Mitigation Project which developed and deployed both an automated and a manual process for managing ISBT 128 labeled blood products. Drove effort from concept, justification, approval, development and implementation within five months to meet stringent industry timeline. Independently developed subject matter expert status on ISBT 128. Serve as Change Lead for various organizational change initiatives. Responsibilities include development of Project Management Plan (PMP), project schedule, business case study, impact analysis, and field surveys. Presented updates to and responded to questions from Senior Management. Authored the Master Deployment Plan (MDP).

Provider of strategic consulting, and business systems integration.Engaged with the American Red Cross on the deployment of a new blood center management system. Conceptualized and developed strategic plans to integrate new software into ARC operations. Co-Authored the Regional Kickoff Guide. Critical contributor to the Deployment Cutover Plan. Developed the project’s contribution to the National Pandemic Preparedness Plan. Provided education on critical projects. Developed and communicated the ISBT conversion process for client customers

Leader of a non-profit national laboratory testing 1.5 million blood samples, employing 120 staff and generating $30 million budgeted revenue annually. Restructured inventory management controls, which minimized waste and ensured sufficient availability. Implemented global problem management system, including cultural change toward deviations. Implemented West Nile Virus (WNV) individual donation testing for all Southern California blood bank customers during the 2004 season. First laboratory in the United States to implement an automated process for WNV testing of blood donors. Drove improvements in the equipment management department, which reduced compliance issues by 40% and eliminated the associated cost of deviations. Restructured health benefits plan, realizing a savings of 10% in selected categories.Accepted role as FDA Responsible Head. Attained FDA licensure and received no significant FDA 483 observations.

Established and managed the quality program at Blood Centers of the Pacific (BCP), which achieved 99% of all quality improvement initiatives. Increased the BCP quality and compliance status score from 18th place to 13th place system-wide based on quality initiatives. Presented quarterly quality status updates to the BCP Board of Directors. Developed quality strategies for the Computer Services Department including introduction of change control and quality oversight for computer system upgrades.

Leadership for production management in blood collection, processing and distribution centers in nine states. Designed a national policy for management of process and equipment validations (Validation Master Plan). Implemented operational enhancements that increased production of high-margin products (Apheresis split product rate increase from 28% to 53% within 24 months and Leukoreduced blood production rate increase from 11% to 71% within 20 months). Developed and implemented strategies that concurrently addressed multiple changes to operations such as: implementation of nucleic acid testing for all Red Cross Blood Centers, co-development of first national production forecast plan, blood center reorganization and redesign, and successful Y2K evaluations.

Directed the assessment of the quality systems that governed operating sites nationally to include viral testing labs, software development centers, blood laboratories, tissue laboratories, clinical and transfusion services, and national headquarters.