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 management/MCHN functions requested by MSPAS. Workstream 1 - GHS-specific regulatory readiness and emerging infectious disease support (50%): • Regulatory readiness: Assess regulatory readiness to prevent, detect, and respond to emerging infectious disease threats, identifying bottlenecks affecting the availability, authorization, quality oversight, and recall of medical countermeasures and outbreak-response products. • Emergency procedures: Develop or update emergency regulatory standard operating procedures (SOPs) that define activation criteria, responsible authorities, expedited assessment and regulatory reliance pathways, emergency importation, documentation, notification, and corrective-action requirements. • Product-quality coordination: Strengthen regulatory coordination for product-quality signals, alerts, recalls, and suspected substandard or falsified products with epidemiological surveillance, public health laboratories, pharmacovigilance, logistics, customs, emergency response, and Agriculture or Environment authorities when a One Health, the intersection of human, animal and environmental health, interface is required. GHS data and indicators: Define GHS-specific regulatory data elements and performance indicators for digital platforms and dashboards, including event-to-regulatory-decision timelines and the regulatory contribution to the 7-1-7 target, without transferring responsibility for detection, notification, or response operations to the a • Outbreak readiness and response: Support outbreak readiness and response through timely advice on regulatory decisions, quality-assured product availability, product safety communications, recalls, and essential nutrition commodities when required during public health emergencies. • Tabletop review: Facilitate at least one tabletop review of the emergency regulatory pathway; document gaps, decisions, responsible parties, timelines, and corrective actions; and incorporate lessons learned into updated procedures. • Portfolio coordination: Coordinate the regulatory GHS workstream with relevant MSPAS units, U.S. Government-supported GHS projects, the Pandemic Fund where applicable, and other partners to align technical approaches, leverage resources, and avoid duplication. • GHS monitoring and reporting: Provide regulatory inputs for GHS monitoring and reporting aligned, as applicable, with the International Health Regulations (IHR), Joint External Evaluation (JEE), IHR States Parties Self-Assessment (SPAR), 7-1-7, Pandemic Fund, and U.S. Government workplans; identify and disseminate effective practices. Workstream 2 - Regulatory quality management, process simplification, and MCHN (50%): • International regulatory diagnosis: Facilitate a self-assessment of the medicine registration quality management system and a gap analysis, covering the legal and regulatory framework, SOPs, staff capacity, document management, scientific assessment criteria, timelines, and transparency; prepare a diagnostic report. • Quality improvement plan: Develop a detailed quality improvement action plan with activities, timeline, required human/technical/financial resources, measurable indicators, responsible parties, and recommendations for legal and regulatory updates needed to advance toward the next level. • SOPs, quality system, and capacity building: Develop or update SOPs for technical and scientific assessment, document control, quality assurance, and continuous improvement; establish the proposed quality management system; train personnel; transfer knowledge; and support documentation readiness for a future external assessment. • Process simplification: Support the monitoring and use of the current medicine registration and control system, support the development of the new system, and reduce the registration backlog through prioritized workflows, continuous-improvement methods, staff support, progress monitoring, and resolution of regulatory and quality-management bottlenecks. • Digital requirements and validation: Define functional and quality requirements, workflows, data elements, and technical specifications for the new medicine registration and control system and the future DNM, and validate proposed technological solutions from a regulatory and quality perspective while preserving the division of responsibilities. • Quality and performance indicators: Define general quality and performance indicators for the digital dashboard to track the backlog, processing times, efficiency, transparency, compliance with quality criteria, and progress toward the next level; coordinate implementation with the health information systems support project. • MCHN product prioritization: Apply transparent, risk-based prioritization to medicines, supplements, specialized nutrition products, and related products designated by MSPAS as MCHN priorities; map regulatory bottlenecks and standardize applicable quality, evidence, and documentation requirements across registration, variations, renewal, and quality alerts. • MCHN coordination: Coordinate, when requested by MSPAS, with maternal, newborn, child health, and nutrition programs and relevant quality, pharmacovigilance, laboratory, and logistics focal points; incorporate appropriate MCHN indicators, product-quality alerts, and recommendations into process-simplification and quality-management products. Cross-cutting implementation functions applicable to both workstreams: • Maintain biweekly operational coordination with MSPAS and the health information systems support project through designated focal points, joint deliverable reviews, technical validation, and documented decisions and agreements. • Provide technical guidance, implementation support, training, and knowledge transfer at national and, when relevant, subnational levels; monitor progress and recommend practical corrective actions to MSPAS leadership. • Document achievements, constraints, lessons learned, and sustainability recommendations for both workstreams, clearly distinguishing GHS-specific results from regulatory quality management and MCHN results. Key Outputs: • GHS 1. GHS regulatory readiness and bottleneck analysis with a prioritized corrective-action plan. • GHS 2. Emergency regulatory SOP package and tabletop review report, including corrective actions. • GHS 3. GHS regulatory data and indicator specifications for digital systems and 7-1-7-related monitoring. • GHS 4. GHS coordination, product-quality alert, and outbreak-support documentation and reporting inputs. • Core/MCHN 1. Quality management diagnostic report and improvement action plan. • Core/MCHN 2. Updated SOPs, proposed quality management system, training program, and external-assessment readiness package. • Core/MCHN 3. Process-simplification priority action plan; current medicine registration and control system/DNM functional and quality requirements; technical validations; and dashboard indicators. • Core/MCHN 4. MCHN regulatory annex covering bottlenecks, prioritization criteria, quality/evidence requirements, indicators, and coordination for MSPAS-designated priority products. Communications: • Regular calls and meetings with MSPAS, relevant multisectoral stakeholders, the U.S. Embassy, and GHSD Washington to review progress, address emerging issues, and maintain alignment. • The Advisor will provide requested information and be available for calls or meetings with MSPAS, the U.S. Embassy, and the U.S. Department of State. REPORTING: The Advisor will submit a brief weekly progress report to the U.S. Embassy/U.S. Department of State and participate in weekly calls as requested. A detailed monthly report will be submitted by the fifth day of the following month and will separately present time, activities, outputs, results, and next steps for (1) GHS-specific work and (2) regulatory quality management/MCHN work, thereby documenting the 50/50 allocation. The Advisor will also provide biweekly technical progress updates to MSPAS and a final report describing measurable results, effectiveness of coordination with the health information systems project, GHS contributions, sustainability recommendations, and lessons learned. Qualifications Education & Professional Background • Bachelor’s degree in health-related sciences • Desirable Masters’s Degree • Spanish Speaking • Intermediate English proficiency desirable • Advanced professional experience in quality management, organizational/institutional development, and systems approaches • Strong knowledge of international quality management standards as applied to medicine regulatory systems Experience • 7+ years in quality management, ideally including continuous improvement work within MSPAS • Proven track record assessing and strengthening regulatory quality management systems, including institutional strengthening with medicine regulatory authorities • Experience integrating a vice ministry/directorate's quality processes into a broader institutional strategy • Skilled in building indicator-based assessment processes tied to targets, results, and health expenditure quality • Cross-functional coordination experience with health information systems and technology projects • Familiarity with Guatemala's health system and regulatory environment, and with international organizations supporting health system strengthening and regulatory reform • (Desirable) Experience with MCHN commodities (including supplements/nutrition products), emergency regulatory procedures, product-quality alerts, and Global Health Security. Skills • Integrates sustainability standards into institutional frameworks • Analyzes and aligns MSPAS needs with national/international best practices • Facilitates self-assessment and institutional diagnostics • Delivers training and knowledge transfer • Communicate effectively with technical and technology teams • Applies systems analysis to optimize workflows and institutional efficiency • Collaborates effectively across multi-project, multidisciplinary environments • Understands international regulatory frameworks and regional harmonization ------------------------------------------------------------------------------------------------------------------------------ Descripción general: El Asesor en Gestión de la Calidad Regulatoria Farmacéutica apoyará al Ministerio de Salud Pública y Asistencia Social (MSPAS), principalmente al Viceministerio de Regulación y al Departamento de Regulación y Control de Productos Farmacéuticos y Afines, en la ejecución de asistencia sanitaria destinada a salvar vidas (LHA, por sus siglas en inglés), en plena consonancia con las directrices de la Orden Ejecutiva Presidencial de los Estados Unidos (EO, por sus siglas en inglés). El énfasis principal de la asesoría será el apoyo técnico, con especial atención a la prevención, detección y respuesta frente a amenazas de enfermedades infecciosas emergentes que afecten la salud pública. La primera línea de trabajo fortalecerá las contribuciones regulatorias a la prevención, detección y respuesta frente a amenazas de enfermedades infecciosas emergentes. La segunda preservará las funciones solicitadas por el Ministerio en materia de registros sanitarios, gestión de la calidad regulatoria, simplificación de procesos y productos prioritarios de salud materna, neonatal e infantil y nutrición (MCHN, por sus siglas en inglés). Aproximadamente el 50 % del nivel de esfuerzo técnico y de los productos del asesor corresponderá específicamente a actividades de seguridad sanitaria global (GHS, por sus siglas en inglés). Estas actividades se centrarán en la preparación regulatoria para contramedidas médicas y productos para la respuesta a brotes, procedimientos regulatorios de emergencia, alertas de calidad de productos, datos para la toma rápida de decisiones y apoyo técnico coordinado durante emergencias de salud pública. El asesor brindará apoyo, pero no asumirá responsabilidad operativa por la detección epidemiológica, la notificación de eventos, el manejo clínico de casos ni las funciones de mando de la respuesta a brotes. El 50 % restante apoyará el Plan de Simplificación de Trámites del MSPAS, la reducción del rezago de registros sanitarios, el avance conforme a la Herramienta Global de Evaluación Comparativa , el desarrollo de un sistema sostenible de gestión de la calidad y la atención basada en riesgos a medicamentos, suplementos y productos afines que el MSPAS designe como prioridades de salud materna, neonatal e infantil y nutrición. El asesor definirá los estándares regulatorios, los procesos, los datos y los requisitos de calidad. El proyecto en apoyo a sistemas de información en salud (SIS) dirigirá el diseño y la implementación tecnológicos para la futura Dirección Nacional de Medicamentos (DNM). El asesor tendrá su sede en la Ciudad de Guatemala durante un período previsto de doce meses, recibirá dirección in situ del Viceministro de Regulación, mantendrá coordinación operativa con el Director del Departamento de Regulación y Control de Productos Farmacéuticos y Afines y presentará informes a la Embajada de los Estados Unidos y al Departamento de Estado de los Estados Unidos, según se describe a continuación. Responsabilidades: Las dieciséis actividades técnicas siguientes establecen una distribución equitativa del 50/50 entre el trabajo específico de GHS y las funciones de gestión de la calidad regulatoria y MCHN solicitadas por el MSPAS. Línea de trabajo 1 - Preparación regulatoria específica de GHS y apoyo frente a enfermedades infecciosas emergentes (50 %): • Preparación regulatoria: Evaluar la preparación regulatoria para prevenir, detectar y responder a amenazas de enfermedades infecciosas emergentes, identificando los cuellos de botella que afecten la disponibilidad, autorización, supervisión de la calidad y retiro del mercado de contramedidas médicas y productos para la respuesta a brotes. • Procedimientos de emergencia: Elaborar o actualizar procedimientos operativos estándar (POEs) regulatorios de emergencia que definan los criterios de activación, las autoridades responsables, las vías de evaluación expedita y los mecanismos de confianza regulatoria, la importación de emergencia y los requisitos de documentación, notificación y acciones correctivas. • Coordinación sobre la calidad de los productos: Fortalecer la coordinación regulatoria respecto de señales relativas a la calidad de los productos, alertas, retiros del mercado y presuntos productos subestándar o falsificados con la vigilancia epidemiológica, los laboratorios de salud pública, la farmacovigilancia, la logística, las aduanas, la respuesta a emergencias y las autoridades de Agricultura o Ambiente, cuando se requiera una interfaz de Una Salud, entendida como la intersección entre la salud humana, animal y ambiental. Datos e indicadores de GHS: Definir elementos de datos regulatorios e indicadores de desempeño específicos de GHS para plataformas digitales y tableros de indicadores, incluidos los plazos desde el evento hasta la decisión regulatoria y la contribución regulatoria a la meta 7-1-7, sin transferir al asesor la responsabilidad por las operaciones de detección, notificación o respuesta. • Preparación y respuesta ante brotes: Apoyar la preparación y respuesta ante brotes mediante asesoría oportuna sobre decisiones regulatorias, disponibilidad de productos con garantía de calidad, comunicaciones sobre la seguridad de los productos, retiros del mercado e insumos nutricionales esenciales cuando sean necesarios durante emergencias de salud pública. • Ejercicio de simulación de mesa: Facilitar al menos un ejercicio de simulación de mesa para examinar la ruta regulatoria de emergencia; documentar las brechas, decisiones, partes responsables, plazos y acciones correctivas; e incorporar las lecciones aprendidas en los procedimientos actualizados. • Coordinación de la cartera: Coordinar la línea