Jan 2004 - Present
President & Principal Consultant
Strategic Concepts, LLC
- Develop teaming agreement to provide acquisition management, systems engineering and logistics services to the Defense Departments Medical Research programs.
- Provided Q&RA consulting support to organizations commercializing IVDs for FDA quality systems regulations for RUO and IUO products.
- Developed technical proposal to provide program management support to the Veterans Administration Office of R&D for their Biomedical and Clinical Science research programs across 88 research facilities.
2006 - 2007
Program Director, Quality & Performance Excellence
- Utilize organizational performance criteria from the Malcolm Baldrige, Robert W.Campbell and the Ron Brown Award for Corporate Leadership to design, lead and implement strategic change initiatives to achieve alignment with organizational strategy, sustain regulatory compliance, achieve cost reduction goals and improve workforce engagement.
- Develop communication plans, budgets and strategic action plans for programs to increase the productivity and effectiveness of the Biomedical Services quality systems, and national infrastructure of human capital, IT, laboratory and manufacturing facility assets.
- Manage a portfolio of quality, productivity and effectiveness programs, and the project teams developing solutions to imporve system performance and achieve organizational excellence.
2004 - 2006
Director Biomedical Headquarters Facility Quality Assurance
- Manage an integrated quality management system. Collaborate with leaders across headquarters and regional facilities to ensure optimal implementation of corrective actions, process improvements, software upgrades, training requirements and procedural changes to manufacturing directives.
- Manage internal audit program and provide Biomed leadership independent assurance that adequate controls are designed and working effectively to address quality system requirements for regulatory compliance across headquarters operation and regional facility assets.
- Provide oversight for the Biomedical Headquarters problem management program and provide direction to problem managers and process owners performing root cause analysis and effectiveness checks when developing preventative and corrective actions. Facilitate organizational learning through increased knowledge capital transfer across facilities.
- Manage the facility's problem portfolio to ensure that the risks to patient safety, product quality, infrastructure, and operational performance are fully addressed. Track and trend facility performance metrics and adjust process design to increase operational effectiveness.
1999 - 2003
Jacobs Technology, Inc.
- David Packard Award for Innovation and Acquisition Excellence, Department of Defense 2003
- Coordinated collaborative research programs between the US Marine Corps Systems Command: Peer-reviewed medical research program involving an anti-fungal product manufactured by a small biotechnology company, and a university-based contract-research-organization with funding from the Congressional Directed Medical Research Program; US-Canadian military collaboration to collect effectiveness data under the "Animal Rule" to support US and Canadian market applications for medical countermeasure to threat agents with funding from the Foreign Comparative Test Program.
- Directed Regulatory Affairs and new product development for Marine Corps Medical Programs. Provided strategic and tactical planning for clinical trial project management, pharmacology/pharmacokinetic characterization, product registration in collaboration with the Program Office for Chemical Biological Medical Defense Systems.
Team Leader, Biomedical Senior Systems Engineer 1999-2003
- Managed interdisciplinary team of 10 analysts, logisticians and engineering consultants supporting $100 Million portfolio of RDT&E acquisition programs.
- Foreign Comparative Test Program; Program Management Award, Department of Defense 2003.
- Developed strategies to meet regulatory requirements for nutritional, pharmaceutical, and medical device market applications; RFI, RFP, supplier audit and manufacturing planning.
- Led strategic planning and implementation team for modernizing global logistics and supply chain organization.
1998 - 1999
Quality & Regulatory Affairs Consultant
EER Systems, Inc
- Prepared Chemical, Manufacturing and Control section for new drug application (NDA), provided cGMP consulting and prepared NDA for US military product sponsor.
- Lead ISO9001 Quality system development, statistical trend analysis, team development, developed and implemented ISO9001 Internal audit plan.
- ISO9000 Internal Auditor
1997 - 1998
Bio-Reg Associates, Inc.
- Provided clinical trial project management, cGMP consulting, product development and regulatory affairs consulting to original equipment manufacturers of medical technology including invitro diagnostics systems, imaging software, and class III devices.
- Assisted domestic and international clients to obtain product registration in the United States, Europe and Japan