The USAID Global Health Supply Chain - Procurement and Supply Management project (GHSC-PSM) procures and distributes health commodities to USAID partner countries. The focus is on HIV/AIDS, malaria, maternal and child health, and reproductive health. GHSC-PSM works to reduce costs and increase efficiencies in global and national supply chains. GHSC-PSM is responsible for forecasting and supply planning, procurement, transportation and warehousing, and in-country distribution, supported by a strong management information system providing accurate real-time data. Also, the project strengthens national supply chain systems and fosters collaboration among supply chain stakeholders worldwide.
We seek a highly motivated, experienced Quality Assurance Specialist who will work as a member of the PSM Malaria Quality Assurance (QA) team that ensures that malaria commodities procured and distributed with financing from the US Presidents Malaria Initiative (PMI) comply with United States Government and country requirements regarding quality, safety, and efficacy and are suitable for their intended use.
- Under the leadership of the PSM Malaria QA Manager assist in implementing health commodity quality assurance (QA) and quality control (QC) processes under the President’s Malaria Initiative (PMI) Task Order (TO2).
- Ensure that QA/QC processes for TO2 commodities are in place, maintained throughout the supply chain and reviewed/revisited periodically to ensure all standard operating procedures reflect the most up-to-date, internationally accepted practices, ensure compliance with evolving innovations, and ensure responsiveness to new products as they become available.
- Support drafting, maintaining and implementing of standard operating procedures and work instructions to ensure TO2 QA/QC processes comply with the WHO Model Quality Assurance System for Procurement Agencies (MQAS) and other international quality standards.
- Review and maintain (in collaboration with TO2 QA staff) appropriate documentation and dossiers supporting the QA/QC procedures for procuring and distributing antimalarial medicines, malaria Rapid Diagnostic Tests (RDTs) and Long Lasting Insecticide Nets (LLINs) for PMI recipient countries.
- Ensure that for each SKU the QC (inspection, sampling and testing) requirements as defined by PMI are available, and ensure with the PSM Source, Fulfillment and Deliver/Return Teams that QA/QC requirements are adequately integrated in their processes throughout the entire supply chain.
- Coordinate with SGS back office that inspection, sampling and laboratory testing are being performed in accordance with the defined requirements.
- Assist in maintaining QA/QC records in the PSM Management Information System (ARTMIS).
- Liaise with the ISO 9001 Quality Management Unit to ensure that ISO 9001 requirements are properly reflected in business processes of TO2 QA.
- Liaise with the Incident and Risk Management unit to ensure that quality related incidents are properly reported and support the implementation of adequate measures to resolve the current incident and avoid reoccurrence.
- Represent TO2 QA Team at routine meetings with PMI.
- Perform any other QA/QC related tasks as directed by the PSM Malaria QA Manager
The candidate we hire will embody PSI’s corporate values:
- Measurement: You use hard evidence to make decisions and guide your work. You set clear goalposts in advance and explain clearly if you need to move them.
- Pragmatism: You’ll strive to deliver the best possible result with the resources available. You won’t be paralyzed by a need to make things perfect.
- Honesty: You own your mistakes and are open about your shortcomings – it’s the only way you’ll learn and improve.
- Collaboration: You’ll quickly establish a mental map of whom you can rely on for what, on your team, at headquarters, and in our country offices – if you try to do it all yourself, you won’t succeed.
- Trust: You accept limits to your sphere of control and give colleagues the benefit of the doubt
- Commitment: You are in it for the long-haul and want to grow with the organization, just like PSI serves its consumers and partners with host-country governments through thick and thin
The basics
- At least three years of experience working in supply chain and health commodity Quality Assurance, experience with US Government projects is an added advantage.
- Understanding of and ability to apply domestic and international guidelines, policies, and regulations regarding the quality, safety, efficacy and use of malaria pharmaceutical products, LLINs and malaria RDTs
- Ability to address the technical challenges in procuring, inspecting, sampling and testing the above products
- Knowledge of and experience with pharmaceutical GMP and GDP requirements
- Experience in implementing programs in low-resource settings is an added advantage
- Excellent interpersonal, written, and oral communications skills
- References will be required. Must be authorized to work in the United States. PSI will not consider work visa sponsorship for this position.