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Quality Compliance Manager - Malaria Products in Arlington at Apple & Associates

Date Posted: 12/5/2018

Job Snapshot

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Job Description

Quality Manager - Global Supply Chain

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 Manager who will ensure that the project performs all activities in compliance with ISO 9001 and GDP requirements and that health commodities procured (pharmaceutical, malaria nets and diagnostic test kits) and distributed meet United States Government and country requirements regarding quality, safety, efficacy and are suitable for their intended use.

Quality Manager - Primary Responsibilities:

  • Ensure that standard operating procedures(SOPs) and work instructions (WIs) are maintained to make sure that malaria QA/QC processes comply with the WHO Model Quality Assurance System for Procurement Agencies (MQAS) and other international quality standards, kept up-to-date with latest developments, comply with evolving innovations, and are responsive to new products as they become available.
  • 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, including timely receipt by the QA team of information from all teams to adequately schedule QA/QC activities, and including warehousing and transportation of malaria commodities only by contractors that work in compliance with Good Distribution Practices (GDP) requirements.
  • Ensure that for each product the QC (inspection, sampling and testing) requirements as defined by PMI are available and product quality requirements correctly reflected in the catalogue.
  • Review tender documents to ensure that they include agreed QA/QC requirements and procedures and support the evaluation of bids from a QA perspective.
  • Coordinate with SGS back office that inspection, sampling and laboratory testing are being performed in accordance with the defined requirements.
  • Review inspection and test results and release health commodities for the QC part of the activities.
  • Investigate out of specifications and quality related incidents, support the drafting of investigation reports, provide a final recommendation of acceptance or rejection of the commodities, and monitor the implementation of corrective actions or improvements as applicable.
Quality Manager Additional Responsibilities:
  • Coordinate analyses on quality trends based on accumulated data and propose corrective actions and/or (in consultation with PMI) adopt QC requirements as necessary.
  • Collaborate with other international organizations to harmonize quality assurance practices.
  • Ensure that PSM M&E and CLEAR teams are provided with data and information for regular reporting and provide regular performance analyses to USAID.
  • Represent the PSM malaria QA/QC team in meetings with PSM teams and PMI.
  • Perform any other QA/QC related tasks as directed by the PSM QA Manager.

Educational, Required Skills & Competencies:
  • At least seven years (7) of experience working in quality assurance compliance with an understanding of US Government and developing country standards.
  • Graduate degree in pharmacy, chemistry, or related field is preferred or the possession of a Bachelor’s degree in the same field and an additional three years of experience beyond the seven required above may substitute for a graduate degree.
  • Demonstrated 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, diagnostic supplies, and equipment.
  • Demonstrated ability to develop and maintain a robust risk-based quality assurance strategy incorporating a stringent and comprehensive QC platform that helps to inform and support the overall QA program for all non-IRS malaria commodities procurement.
  • Demonstrated experience in interacting with senior US and foreign government officials, multilateral partners (e.g. WHO), bilateral partners, and other donor agencies (e.g. UNITAID, the World Bank, the Global Fund).
  • Demonstrated experience in implementing QA/QC programs in low-resource settings with fragile health care systems and weak infrastructure.
  • Excellent interpersonal, written, and oral communications skills.
  • Team player