Medical Products Regulatory Systems Strengthening Consultant

The United States Pharmacopeial Convention (USP) is a scientific nonprofit organization that establishes worldwide standards for the quality, identity, strength, and purity of medicines, food ingredients, and dietary supplements. USP is currently implementing the USAID-funded Promoting the Quality of Medicines Plus (PQM+) program. This initiative aims to bolster medical product quality assurance systems sustainably in LMICs. PQM+’s core goals encompass enhancing governance of quality assurance (QA) systems, improving regional and country regulatory systems, boosting financial support for QA, increasing the supply of quality-assured essential medicines, and advancing global learning in medical product QA. In line with this, PQM+ is seeking the services of a local consultant with expertise in pharmaceutical regulatory system strengthening, based in Maseru, Lesotho. The consultant will have expertise in pharmaceutical systems strengthening and medicines regulatory systems strengthening. The selected candidate will be responsible for providing technical assistance in the areas of pharmaceutical regulatory systems strengthening and pharmaceutical quality assurance. He/she will support PQM+ technical advisors based in the region, in the USA and beyond to facilitate the review, development or adaptation of regulations, directives, manuals, guidelines, procedures and other relevant tools for pharmaceutical policy and regulation; and will actively promote their proper implementation, including training of relevant technical counterparts in Lesotho. Additionally, he/she will act as the main liaison person between in-country, regional and home office teams and provide technical assistance towards building the regulatory capacity of the Lesotho Pharmacy Department. The consultant will work collaboratively with PQM+ regional staff and other consultants under the direct supervision of the PQM+ Senior Program Manager and the overall guidance of the PQM+ Director for Eastern and Southern Africa.The main scope of the work includes, but is not limited to, providing technical support towards strengthening:

• Regulatory systems of the Lesotho regulatory unit within the Pharmacy Department.Local coordination, arranging and participating in meetings; and making follow-ups.Local training support and liaison for the Lesotho Pharmacy DepartmentMonitoring, documentation and reporting of PQM+ activities.Implementing relevant actions in the institutional development plan (IDP) of the regulatory unit, towards advancing its World Health Organization Global Benchmarking Tool (WHO GBT) maturity level.

Key Responsibilities

• Supports PQM+ regulatory systems strengthening technical activities focusing on the WHO-GBT, under the guidance of the regional and US based technical teams.Supports the development and implementation of country work plans and budgets.Collects and reports program data and indicators; documents and translates program information; and helps in coordinating in-country program logistics for implementation of workplan activities.Performs other duties as assigned by the senior program manager or Director, Eastern and Southern Africa

Deliverables

• Meeting notes and reports for all PQM+ represented meetings with in-country partners. Weekly activity summaries and detailed monthly activity reports (including deliverables).Technical reports or documents as applicable.Other deliverables as requested.

Qualifications and Experience

• Bachelor’s degree in pharmaceutical sciences.Master’s degree in pharmaceutical sciences/pharmaceutical quality assurance and quality control of medicines; or public health and management, preferred.At least 10 years’ hands-on experience in pharmaceutical systems strengthening, preferably regulatory systems strengthening.Effective communication skills and fluent in spoken and written English language.Ability to build relationships and interact effectively with technical experts, other partners, and donor agencies.Experience working with USAID projects preferred.Results driven with demonstrated successful outcomes.Must possess ability to work independently and manage multiple priorities in a demanding environment.Ability to demonstrate the highest degree of ethics and integrity.Excellent interpersonal and organizational skills with strong attention to detail.Citizen of Lesotho, permanent resident or holder of a valid work permit

Period of PerformanceSeptember 15, 2023 – August 31, 2024. Renewable depending on availability of country funding and satisfactory work performance by the consultant.

Please send your curriculum vitae, 3 references, and your hourly rate to ATTN: Hana Keno, Senior Procurement Specialist, at [email protected] by the closing date of August 25, 2022 When submitting your application, write “Medical Products Regulatory Systems Strengthening consultant – Lesotho” in the email subject line.