Quality Assurance Manager, Health Products Supply Chain

Arlington, Virginia, United States
Apply by 16 October 2018
Senior-level , Full-time staff position
Posted on 17 August 2018

Job Description

Chemonics seeks a Quality Assurance Manager for Health Products Supply Chain to join the USAID Global Health Supply Chain - Procurement and Supply Management project (GHSC-PSM). 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.


The Quality Assurance Manager will ensure that the project performs all activities in compliance with ISO 9001 and GDP requirements and that health commodities procured and distributed meet United States Government and country requirements regarding quality, safety, efficacy and are suitable for their intended use. We are looking for individuals who have a passion for making a difference in the lives of people around the world.



Responsibilities Include:
  • Develops, drives and executes the Quality Assurance strategy, mission and vision for all of GHSC-PSM
  • Leads the Quality Assurance Team, and promotes staff development through coaching, mentoring, and facilitating professional growth opportunities
  • Liaises with the GHSC QA Contract, which is responsible for ensuring HIV/AIDS, maternal and child health, and reproductive health commodities procured by GHSC-PSM comply with international quality, safety and efficacy standards and are suitable for their intended use
  • With inputs from GHSC-QA determines GHSC-PSM approach to all QA issues and proactively drives timely accomplishment of all QA tasks, in compliance with relevant policies, rules, regulations and international standards
  • Provides guidance to staff ensuring registration of key products in countries, guides the building of a registration database for use across the project, and refines standard operating procedures related to registration for better tracking and use
  • Ensures that QA/QC processes 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
  • Ensures alignment of QA procedures with Source, Deliver/Return, Risk, Country Programs, Field Offices and other relevant teams on GHSC-PSM.
  • Liaise with Source, Deliver/Return, Risk, Country Programs and other project units with regards to QA related matters
  • Liaises with the Quality Management Unit to ensure that quality management requirements are properly reflected in business processes
  • Manages and coordinates the handling of quality related incidents, involve responsible project units as applicable and follow-up that the incidents are resolved
  • Liaises with the Incident and Risk Management unit to ensure that incidents are properly reported and support the implementation of adequate measures to avoid re-occurrence
  • Ensures that GDP requirements are properly adhered to by all project units and subcontractors by review of certification/documentation, and performing and/or supporting audits
  • Provides inputs to the GSC Strategy Team and the Sourcing Governance Board. Guides the pre-qualification and evaluation of prospective and currently approved commodity suppliers and the evaluation of PSM storage and transport conditions
  • Ensures contracts with suppliers include the appropriate QA requirements and conducts surveillance to ensure compliance and supplier accountability
  • Identifies problems associated with theft, deterioration or other diversion of supplies and recommend corrective measures
  • Oversees product recalls, coordinate with relevant project units the identification of the recalled product, the prevention of its delivery to customers, collection, quarantine and/or destruction, and the notification of other stakeholders
  • Collaborates with other pharmaceutical-focused programs, coordinate with other international organizations to harmonize quality assurance practices

Qualifications:
  • At least seven years of experience working in supply chain and pharmaceutical QA compliance with applicable US Government and country requirements regarding quality at a managerial level
  • Knowledge of maintaining robust strategy in collaboration with QC activities that fit within the overall QA program
  • Knowledge of and experience with GDP requirements
  • Understanding of and ability to apply domestic and international guidelines, policies, and regulations regarding the quality, safety, efficacy and use of pharmaceutical products
  • Experience in implementing programs in low-resource settings
  • Excellent managerial, interpersonal, written, and oral communications skills
  • Experience in interacting with senior US and foreign government officials
  • Demonstrated leadership, versatility, and integrity

About the Organization

Owned entirely by employees, Chemonics is an ISO-9001 certified international development company. For more than 40 years, we have partnered with local and international organizations to promote social and economic change around the world.