Pharmaceutical Regulatory Quality Management Advisor / Asesor en gestión de la calidad regulatoria farmacéutica, DOS LEAP Global - Guatemala

Dexis is a dynamic professional services firm dedicated to partnering with government and community leaders both in the U.S. and internationally to achieve critical social outcomes in a rapidly changing world. At Dexis, you will experience a corporate culture of inclusiveness, respect, fairness, and trust. You will be given the means and mentorship needed to succeed, and your creativity will be rewarded. LEAP Program Description Global Solutions Ventures (GSV) – a joint-venture partnership between ZemiTek, LLC and Dexis Consulting Group – is implementing the Long-term Exceptional Technical Assistance Project (LEAP Global), a mechanism originally used by USAID to battle against infectious diseases such as malaria, HIV/AIDS, tuberculosis, neglected tropical diseases, and pandemic influenza. As of July 1, 2025, LEAP Global transitioned to the U.S. Department of State (DOS). This initiative aims to address the complex human resource challenges faced by national infectious disease programs in the USA-supported countries. The intervention of this project is to hire and embed technical expert advisors and subject matter experts within government entities. By directly embedding the technical expertise within the national programs, LEAP provides long-term, sustainable lifesaving support to empower host governments to lead and manage key aspects of their infectious disease portfolios and improve coordination between the U.S. Government and the host country. About the Position The Pharmaceutical Regulatory Quality Management Advisor will support the Ministry of Public Health of Public Health and Social Assistance (MSPAS), principally the Vice ministry of Regulation and Control of Pharmaceutical and Related Products in carrying out life-saving health assistance (LHA) in full alignment with the U.S. Presidential Executive Order (EO) directives. The primary focus of the Adviser will be technical support with a special emphasis on preventing, detecting, and responding to emerging infectious disease threats which impact public health. The first workstream will strengthen regulatory contributions to preventing, detecting, and responding to emerging infectious disease threats. The second will preserve the Ministry-requested functions for sanitary registration, regulatory quality management, process simplification, and priority MCHN products. Approximately 50 percent of the advisor's technical level of effort and outputs will be GHS-specific. These activities will focus on regulatory readiness for medical countermeasures and outbreak-response products, emergency regulatory procedures, product-quality alerts, data for rapid decision-making, and coordinated technical support during public health emergencies. The Advisor will support, but will not assume operational responsibility for, epidemiological detection, event notification, clinical case management, or outbreak command functions. The remaining 50 percent will support the MSPAS Process Simplification Plan, reduction of the sanitary registration backlog, advancement from global benchmarking tools, development of a sustainable quality management system, and risk-based attention to medicines, supplements, and related products designated by MSPAS as priorities for maternal, newborn, and child health and nutrition. The advisor will define the regulatory standards, processes, data, and quality requirements. The health information systems support project will lead the technological design and implementation for the future National Directorate of Medicines (DNM). The advisor will be based in Guatemala City for an anticipated twelve-month period, receive onsite direction from the Vice Minister of Regulation, maintain operational coordination with the Department Director, and report to the U.S. Embassy/U.S. Department of State as described below. Responsibilities The following sixteen technical activities establish an equal 50/50 allocation between GHS-specific work and the regulatory quality managem…