PAHO Consultant - Quality Control Laboratories and the Laboratory Testing Regulatory Function
Organizational Context
The Pan American Health Organization (PAHO) serves as the Regional Office for the Americas of the World Health Organization (WHO).
Job Purpose
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.
Responsibilities
Support NRAs in strengthening the Laboratory Testing (LT) function under the GBT, including gap diagnostics and technical accompaniment. Provide technical assistance for developing and updating SOPs, technical guidelines, and laboratory quality management tools. Support the development and updating of laboratory components of Institutional Development Plans (IDPs). Assist in pathways toward WHO prequalification or accreditation of national QCLs. Support NQCL in articulating its involvement in other essential regulatory functions. Provide technical expertise on the assessment of quality testing of Substandard and Falsified Products. Support the creation and facilitation of a regional technical working group on reliance in laboratory testing. Support the development of training resources for regulatory quality control laboratory staff. Maintain and strengthen collaboration with regional laboratory networks and strategic partners.
Work Experience
Minimum thirteen (13) years of progressive experience in quality control laboratories for medical products, in an official or equivalent capacity. 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. Must be based in the Region of the Americas.
Skills
Quality management systems, analytical method validation, OOS/OOT management and CAPA, trend analysis and data management, equipment management and calibration, reference standards management, documentary management in regulatory environments, technical support to regulatory authorities, GBT framework, ISO/IEC 17025, WHO prequalification, GLP, technical writing, workshop facilitation, applied training.