Z

Zemitek

Federal professional services: program management, IT

Pharmaceutical Regulatory Quality Management Advisor

Full-TimeUpdated on 10/15/2026Deadline 8/14/27
No salary listed
Senior
Bachelor's, Master's
Guatemala City, Guatemala
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A bachelor's degree in health-related sciences.
  • Advanced professional experience in quality management, organizational and institutional development, and systems approaches.
  • Strong knowledge of international quality management standards as applied to medicine regulatory systems.
  • At least 7 years of experience in quality management, ideally including continuous-improvement work within MSPAS.
  • A proven track record assessing and strengthening regulatory quality management systems, including institutional strengthening with medicine regulatory authorities.
  • Experience integrating a vice ministry or directorate's quality processes into a broader institutional strategy.
  • Experience 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.
  • Ability to integrate sustainability standards into institutional frameworks.
  • Ability to analyze and align MSPAS needs with national and international best practices.
  • Ability to facilitate self-assessment and institutional diagnostics.
  • Ability to deliver training and knowledge transfer.
  • Ability to communicate effectively with technical and technology teams.
  • Ability to apply systems analysis to optimize workflows and institutional efficiency.
  • Knowledge of international regulatory frameworks and regional harmonization.
Responsibilities
  • Assess regulatory readiness for emerging infectious disease threats and identify bottlenecks affecting availability, authorization, quality oversight, and recall of medical countermeasures and outbreak-response products.
  • Develop or update emergency regulatory standard operating procedures defining activation criteria, responsible authorities, expedited assessment and reliance pathways, emergency importation, documentation, notification, and corrective-action requirements.
  • Strengthen coordination on 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 interface is required.
  • Define GHS-specific regulatory data elements and performance indicators for digital platforms and dashboards, including event-to-regulatory-decision timelines and regulatory contribution to the 7-1-7 target, without assuming responsibility for detection, notification, or response operations.
  • Support outbreak readiness and response with timely advice on regulatory decisions, quality-assured product availability, product safety communications, recalls, and essential nutrition commodities during public health emergencies when required.
  • Facilitate at least one tabletop review of the emergency regulatory pathway, document gaps, decisions, responsible parties, timelines, and corrective actions, and incorporate lessons into updated procedures.
  • Coordinate the regulatory GHS workstream with relevant MSPAS units, U.S. Government-supported GHS projects, the Pandemic Fund when applicable, and other partners to align technical approaches, leverage resources, and avoid duplication.
  • Provide regulatory inputs for GHS monitoring and reporting aligned, as applicable, with the International Health Regulations, Joint External Evaluation, IHR States Parties Self-Assessment, 7-1-7, Pandemic Fund, and U.S. Government workplans; identify and disseminate effective practices.
  • Facilitate a self-assessment of the medicine registration quality management system and a gap analysis covering the legal and regulatory framework, standard operating procedures, staff capacity, document management, scientific assessment criteria, timelines, and transparency; prepare a diagnostic report.
  • Develop a detailed quality-improvement action plan with activities, timelines, required human, technical, and financial resources, measurable indicators, responsible parties, and recommendations for legal and regulatory updates needed to advance to the next level.
  • Develop or update procedures 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.
  • Support monitoring and use of the current medicine registration and control system, support 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.
  • Define functional and quality requirements, workflows, data elements, and technical specifications for the new medicine registration and control system and future National Directorate of Medicines; validate proposed technological solutions from regulatory and quality perspectives while preserving the division of responsibilities.
  • Define general quality and performance indicators for the digital dashboard to track backlog, processing times, efficiency, transparency, compliance with quality criteria, and progress toward the next level; coordinate implementation with the health information systems support project.
  • Apply transparent, risk-based prioritization to medicines, supplements, specialized nutrition products, and related products designated by MSPAS as maternal, newborn, and child health and nutrition priorities; map regulatory bottlenecks and standardize applicable quality, evidence, and documentation requirements across registration, variations, renewal, and quality alerts.
  • Coordinate, when requested by MSPAS, with maternal, newborn, and child health and nutrition programs and relevant quality, pharmacovigilance, laboratory, and logistics focal points; incorporate relevant indicators, product-quality alerts, and recommendations into process-simplification and quality-management products.
  • 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.
  • Participate in 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.
  • Provide requested information and be available for calls or meetings with MSPAS, the U.S. Embassy, and the U.S. Department of State.
  • Submit a brief weekly progress report to the U.S. Embassy and U.S. Department of State and participate in weekly calls as requested.
  • Submit a detailed monthly report by the fifth day of the following month, separately documenting time, activities, outputs, results, and next steps for GHS-specific work and regulatory quality-management/MCHN work.
  • Provide biweekly technical progress updates to MSPAS and a final report describing measurable results, coordination effectiveness with the health information systems project, GHS contributions, sustainability recommendations, and lessons learned.
Desired Qualifications
  • A master's degree.
  • Intermediate English proficiency.
  • Experience with maternal, newborn, and child health and nutrition commodities, including supplements and nutrition products; emergency regulatory procedures; product-quality alerts; and Global Health Security.

About the company

ZemiTek is a small, woman-owned professional services firm serving federal clients nationwide. It provides tailored solutions across global security, energy, economic development, and more, with services including program management, training and learning development, IT solutions, operational support, and monitoring and evaluation. The company works by partnering with federal agencies to plan, implement, and manage programs, deliver training, deploy IT systems, provide operational support, and monitor outcomes to ensure programs perform well. ZemiTek differentiates itself through its focus on customized, domain-spanning services for government clients, its status as a woman-owned small business, and its combination of capabilities across program management, technology, training, and evaluation. Its goal is to help federal agencies operate at peak performance and achieve mission results by delivering practical, integrated solutions.

Company Size

11-50

Company Stage

N/A

Total Funding

N/A

Headquarters

Bethesda, Maryland

Founded

2007

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Simplify's Take

What believers are saying

  • ZemiTek secured a $49.9M USAID award on a standalone basis in 2024.
  • The February 2026 Polaris GWAC can feed task orders through March 2031.
  • CMMI Level 3 strengthens bid credibility for federal clients in 2026 and 2027.

What critics are saying

  • USAID dependence creates budget and recompete risk when ESI-2 ends March 2025.
  • The November 2025 D.C. employment case risks discovery, costs, and reputational damage.
  • If federal awards stall, ZemiTek's 2028 contract pipeline becomes an existential concentration trap.

What makes Zemitek unique

  • ZemiTek won Polaris WOSB GWAC in February 2026, widening federal access.
  • ZemiTek pairs USAID contractor depth with GIS-backed analytics and process maturity.
  • ZemiTek earned CMMI Level 3 in August 2026 across development and services.

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Zemitek
Nov 9th, 2021
ZemiTek recognized as Most Promising Project Management Solution Provider 2021

ZemiTek was recognized as the “Most Promising Project Management Solution Provider 2021” by CIO Review.