Lead a multidisciplinary team of 15 staff covering budget and finance, operations, IT, human resources, and procurement. Provide leadership, coordination, management, and administrative support for HIV/AIDS, tuberculosis (TB), malaria, and global health security programs. Advise the Deputy Country Director and senior staff on management and operations issues. Manage 12 procurement and service contracts worth $1.9 million. Develop and implement standard operating procedures to assure business continuity and minimize down time.HIGHLIGHTS• Develop the $14.9 million operations budget. Control the budget by overseeing financial expenditures, analyzing budget variances, and maintaining systems and processes for managing funds. Take initiative to identify cost savings. • Develop an operational plan to achieve program goals, ensure efficient operations, and improve customer service and program performance through analysis of processes, practices, and procedures. • Interpret and apply Embassy policies, rules, and regulations and resolve complex and/or sensitive matters. • Organized 2019 staff retreat and presented on ‘win-win’ negotiating strategies for Country Operating Plan (COP) negotiations.

Managed 32 cooperative agreements (coags) worth $142 million that financed HIV/AIDS and TB prevention and treatment programs. Recipients included the Ministry of Health, the Prime Minister’s Office, international and local NGOs, and multilateral organizations. Supervised six locally-employed coag staff and two U.S. direct-hire project officers. Reviewed work plans, held monthly partner management meetings, used key performance indicators (expenditure analysis, pipeline, and burn rate reports), Site Improvement Monitoring System information, and Monitoring and Evaluation data to ensure partner performance and compliance with Federal regulations. Provided remediation advice as necessary. Served as international project officer on seven in-country coags and point of contact for ten headquarter-managed coags.HIGHLIGHTS• Oversaw reprogramming, redirections, grantee-initiated supplements, deobligations, the recovery of unliquidated obligations and the removal of scientific and administrative restrictions.• Proposed and developed an operational plan for CDC Tanzania’s Partner Management Model, including writing standard operating procedures (SOPs) and creating performance metric tools and protocols.• Achieved a score of 3.3/4.0 on the Country Monitoring and Accountability System (CMAS) Management and Leadership scorecard and 3.4/4.0 on the CMAS Strategic Planning scorecard.

Managed the Office of Regulatory Affairs’ international program. Managed international regulatory cooperation on inspections, adverse events, recalls, and imports. Shared non-public technical information under strict procedures.HIGHLIGHT• Successfully managed six audits of FDA regulatory systems by foreign regulatory authorities. Choreographed the audits by preparing staff, setting standards, planning site visits, and intervening to resolve issues when needed. Coordinated audit response, wrote an SOP, and received awards for outstanding performance.

Managed regulatory cooperation with the European Commission (EC), European Union (EU) member states and non-member states on pharmaceuticals, biologics, medical devices, food safety, and cosmetics.HIGHLIGHTS• Analyzed global health policy issues such as pharmaceutical track and trace programs and new drug safety regulatory authority. My research stimulated a request for a new drug safety authority from US Congress which was incorporated into the FDA Safety and Innovation Act of 2011 (Title VII, Drug Supply Chain).• Participated in the development and implementation of regulatory programs under the Food Safety Modernization Act of 2011 and the Generic Drug User Fee Act of 2012.• Initiated and managed a global response to infusion pump failures resulting in increased user awareness, improved device design, and reduced adverse events.

Managed regulatory cooperation with the EC, EU member and non-members on pharmaceuticals, biologics, food safety, medical devices, and cosmetics.Accomplishments- Represented FDA in the US government interagency Health Systems Strengthening Working Group as part of the Global Health Initiative.- Managed two audits of US regulatory systems.- Organized technical information exchanges with foreign agencies on drugs, biologics and medical devices.

Served in multiple capacities as organization representative, conference participant, liaison with foreign ministries, and developed international standards. Managed FDA participation in the Organization for Economic Cooperation and Development committees and working groups. Facilitated multinational cooperation on melamine in dairy from China, heparin from China, and drug eluting stents.Served as an FDA representative on the Global Harmonization Task Force Steering Committee, a multilateral forum that guides medical device regulatory harmonization. Prepared position papers and talking points for the negotiations and assisted in leading FDA delegation.From May 2007 to September 2008, managed FDA’s relationship with Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency covering medicinal products. Increased cooperation to include food safety issues.Coordinated the Agency’s participation in and use of international standards through the FDA Standards Committee and worked on food safety, pharmaceutical and cosmetic standards being developed in the International Organization for Standardization (ISO). Provided training and technical assistance to FDA experts on international standards issues in food safety, pharmaceuticals, medical devices and cosmetics. Represented FDA on various American National Standards Institute committees.Served as FDA’s international point person on nanotechnology issues, fostering cooperation with partner regulatory agencies on regulatory issues and international activities. Represented FDA on the U.S. government’s Global Issues in Nanotechnology Working Group and served as a member of FDA’s Nanotechnology Task Force.

Worked in the CDC office in Windhoek, Namibia from July to September. Participated in monitoring and evaluation, care and treatment, health systems strengthening, and laboratory testing working group meetings and COP negotiations. Facilitated a five-day meeting for NGOs and government agencies to present the 2011 COP and receive feedback. Analyzed Namibia Institute of Pathology’s testing practices to confirm pricing and test frequency issues.

Led CLSI, a standards-development organization in the medical testing and in vitro diagnostic fields, in transforming from a national to a global association.HIGHLIGHTS- Designed and implemented a global business plan that resulted in increased non-US sales, greater global recognition, higher volunteer participation, and improved application of products and services.- Developed and managed organizational relationships including CLSI’s role as a World Health Organization Collaborating Center for Clinical Laboratory Standards.- Managed the development of ISO standard 15189, Medical laboratories – Particular requirements for quality and competence. ISO 15189 has been used to certify thousands of medical laboratories worldwide.- Assisted in developing the global system for medical laboratory accreditation based on quality systems management by working with the International Laboratory Accreditation Cooperation and the International Accreditation Forum to use ISO 15189 for certifying medical laboratories.