[Hiring] International PAHO Consultant - Development of NIP Quality Management Tools @Pan American Health Organization

Role Description

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

• Consulting Services for the Development of Procedures and Tools for Managing Nonconformities and Incidents for National Immunization Programs in the Americas
• Modality: Virtual / Off-site
• Duration: 6 months, with possible extension depending on performance and availability of funds

1. Introduction

National Immunization Programs (NIPs) play a fundamental role in protecting populations against infectious diseases. To ensure the provision of safe and effective vaccines and maintain public trust, it is essential to have robust procedures for managing nonconformities and errors in vaccine administration, including the implementation of corrective actions that enable the prevention, timely detection, root cause analysis, response, and resolution of process deviations from the moment the vaccine is received by immunization programs.

Nonconformity can be defined as a failure to meet a requirement related to products, services, or processes. In the context of patient safety, a nonconformity that poses a risk of harm to a person is called an incident. These situations can affect the quality of the biological product, lead to adverse events, result in vaccine wastage, and cause missed opportunities for immunization.

In the Americas region, Chile has a specific formal system for managing program errors; in other countries, reporting may be incorporated into the ESAVI system although without systematic investigation and decision-making processes. Likewise, incidents involving massive vaccine losses associated with management failures have been reported in other countries. In this context, a consultant is needed to develop a practical framework (regional manual and tools) to guide countries in implementing procedures for nonconformities, incident management, and corrective action.

2. Objectives of the Consultancy

2.1 General Objective

• To develop tools and a regional manual to guide countries in the Americas in implementing procedures for managing nonconformities and incidents related to vaccine safety risks and vaccination processes.

2.2 Specific Objectives

• Conduct a situational analysis of the status of nonconformity and incident management in the National Immunization Programs (NIPs) of the Americas region, identifying gaps, existing practices, and monitoring capabilities.
• Review international reference frameworks (including ISO 9001/9000) on nonconformity management and corrective actions applicable to the context of vaccines and vaccination processes.
• Develop a Regional Manual on Nonconformity and Incident Management for National Immunization Programs (NIPs), with accompanying practical tools (recording forms, flowcharts, risk matrices, root cause analysis guides, corrective/preventive action plans, and monitoring indicators).
• Conduct the technical validation process for the manual and its tools with key regional stakeholders and incorporate the corresponding adjustments.
• Develop a methodological proposal for a proof-of-concept study on the national adaptation of the Regional Manual in two countries in the region serving as pilot countries.

3. Responsibilities of the Consultant

The selected consultant will be responsible for carrying out the following activities under the technical supervision of PAHO’s CIM Safe Vaccination Team:

• Defining the methodology for identifying and analyzing sources of information on the capacity of National Immunization Programs (NIPs) to manage nonconformities related to vaccine management processes and the vaccination process.
• Defining a concise set of indicators (quantitative and qualitative) of NIPs’ capacity to manage nonconformities and implement corrective and preventive actions (CAPA), including monitoring and continuous improvement.
• Designing and conducting a rapid assessment/survey on the degree of implementation of nonconformity and corrective action procedures in the region’s NIPs.
• Preparation of a situational analysis report on the management of temperature deviations and programming errors, including gaps, existing practices, and monitoring capabilities.
• Rapid review of literature and international frameworks (ISO 9001/9000 and specific references for the cold chain and process quality) applicable to vaccine management and the vaccination process.
• Definition of the structure (table of contents) and preparation of the first draft of the Regional Manual for the Management of Nonconformities and Incidents for the National Immunization Program (PNI), with accompanying tools: record forms, flowcharts, risk matrices, root cause analysis guide, corrective/preventive action plan, indicators, and monitoring dashboard.
• Conducting the technical validation process for the manual and tools with key regional stakeholders, and preparing a proposal for adjustments.
• Formulating the methodological proposal for the national adaptation proof of concept (guidelines for two countries in the region to serve as proof-of-concept pilot countries), including implementation guidelines, outcome measurement, and integration with PNI evaluation methodologies.

4. Required Profile

4.1 Education

• Essential: Undergraduate and/or graduate degree in medicine, pharmaceutical chemistry, pharmacology, public health, vaccinology, or other health-related fields.
• Essential: Formal training in quality management systems (e.g., ISO 9001), health risk management, continuous improvement, or related areas applicable to QMS. Training in quality auditing, CAPA, and root cause analysis is preferred.
• Essential: No ties to the pharmaceutical industry.
• Desirable: Knowledge and experience with nonconformity procedures and corrective action (CAPA) in healthcare, the vaccine supply chain, or public services.
• Desirable: Knowledge of ISO 9000/9001 frameworks as applied to healthcare services.

4.2 Experience

• Essential: Minimum of 5 years of experience in the areas described below:
• Experience in the evaluation, design, or implementation of quality management systems (QMS) or health risk management systems.
• Experience in planning and implementing nonconformity procedures and corrective/preventive actions (CAPA), including indicators and follow-up.
• Experience in investigating and managing events related to the quality/safety of health products or services (e.g., program errors, cold chain, adverse events linked to process failures).
• Preferred: Experience with quality processes and management in National Immunization Programs.
• Preferred: Experience in managing nonconformities related to the vaccine cold chain/supply chain, root cause analysis, internal audits, and continuous improvement.

4.3 Language

• Proficiency in Spanish and English (reading and writing).

5. Duration and Location of the Consulting Assignment

5.1 Duration

• The consulting assignment will last six (6) months, from 1 August 2026 to 31 January 2027. The contract term may be extended, subject to the consultant’s satisfactory performance and the availability of funds. The total duration is equivalent to 120 days of actual work, distributed across six deliverables as specified in the deliverables section.

5.2 Work Location

• The consulting work will be conducted entirely virtually and off-site. The consultant may perform his or her duties from any location, provided he or she has a stable Internet connection and is available to participate in virtual meetings coordinated with the PAHO technical team and country counterparts.
• Availability is required to participate in virtual meetings at times compatible with the Washington, D.C., time zone (ET).
• Should an in-person work assignment be required as part of validation or proof-of-concept activities, the corresponding per diem and travel expenses will be covered in accordance with the Organization’s regulations.

6. Additional information

• The professional daily pay rate applied to this consultancy will be $200 (band A).
• 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 online 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.
• 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).
• PAHO will also use the databases of the Council for Higher Education Accreditation and College Navigator to support the validation process.
• Any appointment/extension of appointment is subject to PAHO/WHO Regulations, and e-Manual.
• 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.
• 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.
• 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.
• PAHO/WHO shall have no responsibility whatsoever for any taxes, duties, social security contributions or other contributions payable by the Consultant.