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OBJECTIVE OF THE OFFICE/DEPARTMENT

This is a requisition for employment at the Pan American Health Organization (PAHO)/Regional Office of the World Health Organization (WHO)

Contractual Agreement:

Non-Staff - International PAHO Consultant

Job Posting:

September 10, 2026

Closing Date:

September 20, 2026, 11:59 PM Eastern Time

Primary Location:

Off Site

Organization:

IMT Innovation, Access to Medicines and Health Technologies

Schedule:

Part time

PURPOSE OF CONSULTANCY

Provide specialized technical cooperation to strengthen national and regional quality control laboratories (QCLs) for medicines, vaccines, and other health technologies within the framework of the WHO Global Benchmarking Tool (GBT), contributing to improvements in regulatory maturity, the development and implementation of Institutional Development Plans (IDPs), and the articulation of regional initiatives on reliance, capacity-building, and laboratory networks - in alignment with CSP30.R12 and PAHO's BWP Outcome 2.3.

DESCRIPTION OF DUTIES:

TERMS OF REFERENCE

International Consultancy (IPC) Band C

Regional Consultant on Quality Control Laboratories and the Laboratory Testing Regulatory Function

Contract period:

1 November 2026-31 October 2027

Work modality:

Remote, with occasional travel within the Region of the Americas as required

Duty station:

Remote - candidates must be based in the Region of the Americas

Hiring entity:

Department of Innovation, Access to Medicines and Health Technologies (IMT), Quality and Regulation Unit (IMT/QR)

1. Background

The Department of Innovation, Access to Medicines and Health Technologies (IMT) is responsible for promoting, coordinating, and executing PAHO's technical cooperation to improve equitable access to health technologies, including pharmaceutical products, vaccines, medical devices, diagnostics, and other products, working in an interprogrammatic manner and in collaboration with key partners. The Quality and Regulation Unit (IMT/QR) provides technical cooperation to strengthen the regulatory systems capacity for health technologies through the promotion of international standards, support to countries in regulatory capacity assessment processes, institutional development planning, and human resources competency building. The Unit also promotes regulatory harmonization and convergence in the Region through the Secretariat of the Pan American Network for Drug Regulatory Harmonization (PANDRH), leads regional technical networks and working groups, and provides technical support to the PAHO Regional Revolving Funds on quality assurance and risk management.

This consultancy is part of PAHO's sustained regional efforts to strengthen national and regional quality control laboratories (QCLs) for medicines, vaccines, and other health technologies. Functional and well-resourced QCLs are a cornerstone of national medicines regulatory systems, generating the analytical evidence needed to support marketing authorization decisions, pharmacovigilance, and post-market surveillance, including verification of product quality across the supply chain. In addition to providing technical and scientific input before and after marketing authorization, national QCL staff may also contribute to clinical trial authorizations, participate in regulatory inspections, support the analysis of vigilance data, and provide technical advice for national lot release. Despite significant progress in the Region, strengthening laboratory regulatory capacity remains one of the most technically complex areas of regulatory systems development, requiring specialized expertise, adequate infrastructure, robust quality management systems, and progressive pathways toward international recognition.

As part of its mandate to support the evaluation and strengthening of national regulatory authorities (NRAs) in the Region, PAHO uses the WHO Global Benchmarking Tool (GBT) as the standard methodology for regulatory systems assessment. The Laboratory Testing (LT) function-one of nine regulatory functions assessed by the GBT-covers activities ranging from sample reception and testing methods, through quality management and equipment management, to reporting and decision-making. Supporting NRAs and national quality control laboratories (NQCLs) in progressing along the GBT maturity levels-and, where appropriate, pursuing WHO prequalification or international accreditation-is a priority under PAHO's regional regulatory strengthening mandate.

IMT/QR's work in this area is guided by the PAHO Regional Policy for Strengthening National Regulatory Systems (CSP30.R12), which calls on Member States to strengthen the laboratory function as part of integrated regulatory systems, and to engage with international harmonization standards. It also aligns with the mandate to support laboratory networks and collaborative initiatives with strategic partners including UNODC, USP, WCO, WHO, WOAH, Interpol, and academic laboratories.

To advance this agenda, IMT/QR requires the services of a professional with specialized expertise in QCL operations, the GBT LT function, and regional capacity-building strategies.

2. General Objective

To provide specialized technical cooperation to strengthen national and regional quality control laboratories (QCLs) for medicines, vaccines, and other health technologies within the framework of the WHO Global Benchmarking Tool (GBT), contributing to improvements in regulatory maturity, the development and implementation of Institutional Development Plans (IDPs), and the articulation of regional initiatives on reliance, capacity-building, and laboratory networks - in alignment with CSP30.R12 and PAHO's BWP Outcome 2.3.

3. Specific Objectives

• Support the diagnosis and identification of focal points for a regional Network of Quality Control Laboratories, with a view to strengthening the Laboratory Testing regulatory function across Member States and fostering collaboration, information exchange, and mutual capacity-building among participating laboratories.

• Support NRAs in the Region in assessing and strengthening the Laboratory Testing regulatory function under the GBT framework, including gap identification and the design of corrective and preventive actions.

• Support the implementation of the laboratory components of Institutional Development Plans (IDPs) in prioritized countries.

• Contribute to strengthening the QCL's involvement in, and contribution to, other regulatory functions, including but not limited to marketing authorization, vigilance, lot release, market surveillance and control, and regulatory inspections, in accordance with international standards.

• Facilitate the establishment and functioning of regional technical working groups: (i) to advance recognition and/or reliance on laboratory decisions, data, pharmacopeia standards, and information from other NQCLs and regional or international institutions; and (ii) to develop capacity-building resources for QCL staff under PAHO's REGTEC learning itinerary.
• Strengthening collaboration with regional laboratory networks and strategic partners, including UNODC, USP, WHO, WCO, WOAH, Interpol, and academic laboratories.

• Contribute to the planning, monitoring, and reporting of technical cooperation activities in the area of quality control laboratories, within the framework of donor-funded projects and the IMT/QR program of work.

4. Scope of Services

The consultant will carry out the following activities, organized into six functional areas:

4.1 Regulatory Strengthening and GBT assisted self assessments

• Support NRAs in strengthening the Laboratory Testing (LT) function under the GBT, including gap diagnostics, evidence review, and technical accompaniment in the implementation of improvement actions.

• Provide technical assistance for the development, review, and updating of standard operating procedures (SOPs), technical guidelines, pharmacopeia standards, checklists, and laboratory quality management tools aligned with international standards (ISO/IEC 17025, regional and international pharmacopoeias, GBT).

• Support the development and updating of the laboratory components of Institutional Development Plans (IDPs) in prioritized countries, including the definition of phases, milestones, indicators, and resource requirements.

• Support progressive advancement in GBT maturity levels (e.g., ML3 to ML4) by providing technical accompaniment and, where appropriate, assisting in the exploration of pathways toward WHO prequalification or accreditation of national QCLs.

• Carry out or support on-site technical missions to national quality control laboratories (NQCLs), including through twinning programs and peer-learning initiatives.

4.2 Marketing Authorization and other essential functions - Laboratory and Quality Dimensions

• Support NQCL in clearly articulating and documenting, through standard procedures and relevant records, its involvement in and contribution to other essential functions within the national regulatory system (e.g., marketing authorization, market surveillance and control, regulatory inspections, lot release, among others).

• Provide technical expertise regarding the assessment of quality testing of Substandard and Falsified Products to Detecting, preventing, and responding to illegal or fake medical items.

• Provide recommendations and strategies on quality marketing vigilance programs for sampling products

• Provide guidance to countries regarding Quality claims procedures, SOPs and laboratory testing validations

4.3 Technical Working Group: Reliance in Laboratory Testing

The consultant will support the creation, facilitation, and operation of a regional technical working group on reliance in laboratory testing, aimed at promoting regulatory efficiency through the recognition and use of testing results and laboratory evaluations generated by other jurisdictions or recognized reference laboratories.

• Support the design of the working group's structure, mandate, methodology, and action plan, in coordination with IMT/QR.

• Identify and map current reliance practices in laboratory testing across the Region, including enabling legal frameworks, barriers, and opportunities.

• Facilitate the exchange of experiences among countries and with international partners (e.g., USP, WHO reference laboratories, and others) to strengthen the technical foundation for reliance in laboratory testing.

• Support the development of regional technical guidance or recommendations on reliance in laboratory testing, aligned with convergence initiatives and CSP30.R12.

• Coordinate with any existing working group on reliance in marketing authorization and other regulatory functions to ensure coherence and integration of approaches.

4.4 Training Courses and Resources for the Learning Itinerary

The consultant will support the operation of a regional technical working group on training resources for the learning itinerary of regulatory quality control laboratory staff, aimed at developing, consolidating, and systematizing high-quality educational resources for NRA technical personnel.

• Support the mapping of training needs of regulatory QCL staff in the Region, identifying priorities areas and capacity gaps.

• Contribute to the design, review, and updating of courses, modules, guidelines, and training materials aligned with the GBT and relevant international laboratory standards (quality management, analytical method validation, OOS/CAPA, reference standards management, trend analysis, etc.).

• Support the articulation and integration of LT training resources with the PAHO Virtual Campus for Public Health (VCPH) and other regional learning platforms, promoting their availability and accessibility.

• Facilitate the exchange of training materials, experiences, and good practices among countries, fostering South-South and triangular cooperation.

• Contribute to the design and development of differentiated learning itineraries based on regulatory maturity level and laboratory profile (NQCLs with basic functions, advanced functions, or on a pathway to WHO prequalification).

4.5 Networks, Partners, and Coordination

• Maintain and strengthen collaboration with regional laboratory networks and strategic partners, including PAHO/WHO collaborating centers - such as INCQS (currently in the process of designation as a PAHO/WHO collaborating center) - as well as partners in official relations with PAHO/WHO, including USP, UNODC, WCO, WOAH, Interpol, and academic laboratories in the Region.

• Propose and develop joint work agendas with collaborating centers and strategic partners to advance laboratory strengthening priorities, including twinning programs, proficiency testing schemes, reference standards access, and collaborative technical missions.

• Provide technical inputs to articulate the laboratory function with the PANDRH network and other regional regulatory harmonization and convergence mechanisms.

• Contribute to IMT/QR's technical representation at meetings, events, and platforms on regulatory quality control laboratories at the regional and international levels.

5. Deliverables, Remuneration and Payment Schedule

All products shall be delivered in PDF format, submitted electronically (via email or other method designated by PAHO), within the timelines agreed with the supervisor. Theremunerationcorresponds to PAHO BandCconsultant rates. The total value of the contract is US$84,000 with an estimated dedication time of 80%. Payments will be made in installments upon submission and acceptance of deliverables by the supervisor according to the following schedule:

No. Deliverable / Description / Due date / Payment date / Amount (US$)

1 / Inception report: detailed work plan and activity schedule for the 12-month period; preliminary mapping of prioritized countries and baseline status of the Laboratory Testing function; proposed mandate, structure, and...