PAHO Consultant - Quality Control Laboratories and the Laboratory Testing Regulatory Function

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. The remuneration corresponds to PAHO Band C consultant 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 membership of the two technical working groups. / 18-Dec-26 / 21-Dec-26 / $14,000

2 / First progress report: early advances in technical assistance to at least two prioritized countries; kick-off documentation of both working groups (meeting summaries and agreed workplans); initial mapping of regional reliance practices in laboratory testing. / 26-Feb-27 / 28-Feb-27 / $14,000

3 / Second progress report: advances in IDP laboratory components (minimum two countries); Reliance WG — preliminary regional technical guidance on reliance in laboratory testing (for consultation); / 26-Apr-27 / 30-Apr-27 / $14,000

4 / Third progress report: consolidated mid-year review — technical assistance outcomes (minimum three countries), IDP status, and results of technical missions and partner activities; Reliance WG — revised guidance document incorporating consultation feedback. / 26-Jun-27 / 30-Jun-27 / $14,000

5 / Fourth progress report: Training WG — at least two finalized learning resources (courses, modules or technical guides) ready for publication on the PAHO Virtual Campus for Public Health (VCPH); documentation of good practices and lessons learned in laboratory strengthening. / 26-Aug-27 / 31-Aug-27 / $14,000

6 / Final consolidated report: full systematization of 12-month results (country technical assistance, working groups, laboratory networks, partner activities, training resources produced); lessons learned; recommendations for program continuity; proposed work plan for the following period. Includes finalized versions of all outstanding products. / 26-Oct-27 / 31-Oct-27 / $14,000

TOTAL US$ 84,000

Travel, daily subsistence allowances, and related mission costs are governed by applicable PAHO policies and are not included in the consultancy fee.

6. Contract Period

The consultancy will cover an initial period of twelve (12) months, from 1 November 2026 to 31 October 2027, with the possibility of an extension for up to an additional six (6) months (for a total 18 months), subject to fund availability, operational needs of IMT/QR, and satisfactory performance evaluation.

7. Work Modality and Travel

The work modality is remote. The consultant must be based in the Region of the Americas. Occasional travel to prioritized countries in the Region may be required for technical missions, GBT assessments, workshops, or meetings with strategic partners. Travel and daily subsistence allowances will be governed by applicable PAHO policies and are not included in the consultancy fee.

8. Supervision

The consultant will report to the Advisor, Regulatory System Strengthening for Medicines & other Health Technologies, and will work in close coordination with the IMT/QR technical team and, as appropriate, with PAHO country offices. A minimum of monthly check-in meetings will be held to review progress, in addition to operational coordination as needed.

9. Link to PAHO's Biennial Work Plan (BWP)

This consultancy contributes directly to PAHO's BWP Outcome 2.3: "Access to health technologies, innovation, and production", through the strengthening of the Laboratory Testing regulatory function, the development of NRA technical capacities, the promotion of reliance in laboratory testing, and the fostering of regulatory harmonization and convergence in the Region of the Americas — in implementation of the mandates of resolution CSP30.R12.

10. Consultant Profile and Qualifications

Essential Requirements

• University degree in pharmacy, chemistry, biochemistry, chemical engineering, biomedical sciences, or a related field. Postgraduate training in a relevant area (regulatory affairs, quality management, public health) is desirable.

• Minimum thirteen (13) years of progressive experience in quality control laboratories for medical products, in an official or equivalent capacity (NRA laboratory, WHO reference laboratory, or international organization laboratory).

• Demonstrated experience in at least three of the following technical areas: quality management systems (ISO/IEC 17025 or equivalent); analytical method validation, verification, and transfer; OOS/OOT management and CAPA; trend analysis and data management; equipment management and calibration; reference standards management; documentary management in regulatory environments.

• Experience in providing technical support to regulatory authorities or laboratories in capacity assessment or strengthening processes, preferably under the GBT or comparable frameworks (ISO/IEC 17025, WHO prequalification, GLP).

• Solid technical writing skills and demonstrated ability to facilitate workshops and applied training processes.

• Professional proficiency in Spanish and working knowledge of English (bilingual or equivalent); and working knowledge of English.

• The candidate must be based in the Region of the Americas.

Desirable Characteristics

• Experience in WHO prequalification processes for laboratories or in accreditation by internationally recognized bodies.

• Experience in international technical cooperation and work with regulatory authorities in low- or middle-income countries.

• Knowledge of regulatory reliance frameworks applied to laboratory testing (recognition of analytical results, proficiency testing programs, regional or international reference laboratories).

• Familiarity with the PANDRH network, the former Latin American Network of Official Medicines Control Laboratories (OMCLs), or equivalent regional networks.

• Previous work experience in the United Nations system or multilateral organizations.

IT Competencies

• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

• Familiarity with virtual collaboration tools (Teams, SharePoint, or equivalent).

ADDITIONAL INFORMATION

• This vacancy notice may be used to identify candidates for other similar consultancies at the same level.
• Successful candidates will be placed on the roster and subsequently may be selected for consultancy assignments falling in this area of work or for similar requirements/tasks/deliverables. Inclusion in the Roster does not guarantee selection for a consultant contract. There is no commitment on either side.
• Only candidates under serious consideration will be contacted.
• All applicants are required to complete an on-line profile to be considered for this consultancy. For assessment of your application, please ensure that your profile in the PAHO Career page is updated; all experience records are entered with elaboration on tasks performed at the time. Kindly note that CV/PHFs inserted via LinkedIn are no accessible.
• A written test may be used as a form of screening.
• If your candidature is retained for interview, you will be required to provide, in advance, a scanned copy of the degree(s)/diploma(s)/certificate(s) required for this position. PAHO/WHO only considers higher educational qualifications obtained from an institution accredited/recognized in the World Higher Education Database (WHED), a list updated by the International Association of Universities (IAU)/United Nations Educational, Scientific and Cultural Organization (UNESCO). The list can be accessed through the link: http://www.whed.net/. PAHO will also use the databases of the Council for Higher Education Accreditation http://www.chea.org/search/default.asp and College Navigator, found on the website of the National Centre for Educational Statistics, https://nces.ed.gov/collegenavigator to support the validation process. Some professional certificates may not appear in the WHED and will require individual review.
• Any appointment/extension of appointment is subject to PAHO/WHO Regulations, and e-Manual.
• For information on PAHO please visit: http://www.paho.org
• PAHO/WHO is committed to providing a respectful and supportive workplace for all personnel .
• PAHO is an ethical organization that maintains high standards of integrity and accountability. People joining PAHO are required to maintain these standards both in their professional work and personal activities.
• PAHO also promotes a work environment that is free from harassment, sexual harassment, discrimination, and other types of abusive behavior. PAHO conducts background checks and will not hire anyone who has a substantiated history of abusive conduct.
• PAHO personnel interact frequently with people in the communities we serve. To protect these people, PAHO has zero tolerance for sexual exploitation and abuse. People who commit serious wrongdoings will be terminated and may also face criminal prosecution.
• PAHO/WHO has a smoke-free environment and does not recruit smokers or users of any form of tobacco.
• Applications from women and from nationals of non and underrepresented Member States are particularly encouraged.
• Consultants shall perform the work as independent contractors in a personal capacity, and not as a representative of any entity or authority. The execution of the work under a consultant contract does not create an employer/employee relationship between PAHO and the Consultant.
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