The United States Agency for International Development (USAID) has contracted Social Solutions to recruit and hire qualified individuals for the following position:
Title: Senior Quality Assurance Advisor, Malaria
Location: Washington, DC
Application Deadline: Open until filled
Salary Range: GS 14 equivalent
The U.S. President’s Malaria Initiative is the US Government’s (USG) flagship global malaria initiative led by USAID and implemented together with the Centers for Disease Control and Prevention. The Initiative is results-based, focused, and exhibits a high level of financial and programmatic accountability. In 2015, PMI launched the next six-year strategy, setting forth a new bold vision, and an ambitious goal with specific objectives. The PMI Strategy for 2015-2020 takes into account the progress over the past decade and the new challenges that have arisen, and reflects the U.S. Government’s commitment to work with PMI-supported countries and partners to further reduce malaria deaths and substantially decrease malaria morbidity working towards the long term vision of a world free of malaria.
BACKGROUND: BUREAU FOR GLOBAL HEALTH/OFFICE OF INFECTIOUS DISEASE/DIVISION OF MALARIA
The Bureau for Global Health (GH) serves as the Agency’s primary source of intellectual capital, technical leadership, and donor coordination for the health sector. GH is vested with the responsibility for advancing field-relevant, state-of-the-art research and the transfer of new technologies and approaches to field programs and in technically and programmatically supporting USAID Mission health program implementation in the field. The Office of Infectious Disease (ID) is one of GH’s eight offices. The Malaria Division is one of four divisions of the ID Office. Leadership, management, and oversight of PMI are carried out from the Malaria Division under the leadership of the US Global Malaria Coordinator as are management of USAID’s malaria research investments (most notably vaccine, drug, and insecticide research programs) and USAID’s global partner engagement including WHO and RBM Partnership to End Malaria.
Expansion of malaria prevention and control activities in PMI countries is reliant on a stable supply of quality-assured malaria commodities. PMI provides comprehensive support to countries for planning, forecasting, procurement, distribution and monitoring of malaria commodities. PMI strengthens malaria commodity management and supply chain systems to reduce vulnerabilities in these systems to ensure access to quality malaria commodities by end users. PMI also supports regulatory system strengthening to ensure the quality of malaria products once they enter the country until they reach the end user.
The Senior Quality Assurance Advisor, Malaria (Advisor), sits within the Malaria Supply Chain Branch, and provides technical leadership and oversight support of PMI’s Quality Assurance/Quality Control (QI/QC) activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The Advisor will support the work of PMI staff at USAID headquarters and at PMI country and regional mission programs. The Advisor will work in collaboration with global malaria stakeholders and technical partners, Ministries of Health, and USAID cooperating agencies to provide technical leadership on QA/QC of malaria commodities, strengthening regulatory systems, and improving the availability of quality-assured commodities. S/he will exercise independent judgment in planning and carrying out tasks. S/he will support USG priorities at critical technical and policy forums particularly related to procurement of quality-assured malaria commodities and detecting and mitigating substandard, poor quality, and counterfeit malaria medicines. S/he will provide technical leadership in resolving problems and conflicts, and in taking steps necessary to meet deadlines to ensure PMI-supported malaria commodities are quality assured and reach the end user.
- Provide technical leadership support for the implementation and oversight of PMI’s quality assurance/quality control activities for all PMI-procured malaria medicines and other commodities to ensure only quality assured products are funded for use in PMI and USAID supported programs.
- Develop risk-based QA/QC approaches by product category—pharmaceuticals, diagnostics, and insecticide-treated mosquito nets.
- Engage international donors and UN agencies regarding procurement policies, harmonizing QA/QC practices, and new product introduction.
- Liaise with malaria commodity suppliers and various partners to ensure that programmatic commodities meet PMI quality standards.
- Guide PMI’s approach to detecting and mitigating substandard, poor quality, and counterfeit malaria products.
- Guide PMI’s approaches to maintaining the quality of pharmaceuticals, diagnostics, and insecticide-treated mosquito nets during their movement through the supply chain from point of manufacture through to through provision to beneficiaries
- Work closely with PMI technical teams including case management and vector control to understand their requirements and bottlenecks and to solicit their technical and clinical expertise to inform our quality assurance and commodity management approaches.
- Provide technical guidance and support for PMI-related contracts or agreements to ensure implementation of PMI’s goals and targets particularly related to malaria commodity procurement, coordination, and logistics and quality assurance of malaria commodities.
- Provide recommendations and guidance in keeping abreast of new developments and emerging issues in malaria commodity policy and commodity administration that affect the PMI and share with colleagues.
- Liaise with product development partnerships on product pipelines for critical next generation malaria commodities.
- Support new product introduction including product registration, policy updates, and demand forecasting.
- Liaise with national regulatory agencies including FDA, EMA, and PMI-country regulatory agencies and the World Health Organization pre-qualification programme on quality concerns, site audits, complaints, approvals, etc.
- Support national regulatory harmonization and strengthening efforts including product registration, track and trace requirements, and post-market surveillance.
Management and Country Support:
- Provide technical management support of PMI’s supply chain and related contracts, in collaboration with the COR team(s), to ensure adherence to USG regulations, good procurement practices, effective delivery of appropriate technical assistance and responsiveness to Mission supply chain and commodity needs.
- Provide support to PMI country teams on their managing, ordering, quantifying commodity, logistics, and pharmaceutical management needs.
- Provide technical and programmatic support to one or more PMI focus countries and participate as an integral member of one or more interagency country support teams.
- Provide guidance and support to Missions and PMI country teams on the development of annual country malaria operational plans and assist in monitoring and tracking overall progress of PMI plans and activities.
- Provide advice and technical assistance to Missions involved in malaria efforts
- Provide support to Missions by participating in country support teams, reviewing mission strategies and annual reports and helping them to meet needs for technical and programmatic support.
- Minimum of a Master’s Degree in quality assurance compliance, pharmaceutical management, life sciences, or social sciences from a recognized institution and/or pharmacy degree.
- Minimum of nine years of experience working in quality assurance compliance and management, pharmaceutical management, or related area.
- The candidate will have demonstrated experience in one or more of the following areas: quality assurance and quality control of health commodities; supply chain and logistics management; pharmaceutical management; and identification, prevention and mitigation of substandard, falsified or counterfeit medicines.
- Experience in malaria program design, implementation, coordination and management in developing countries, particularly in Africa preferred.
- Experience collaborating with Ministries of Health and/or National Malaria Control Programs on the implementation of technically sound malaria control prevention and treatment interventions preferred.
- Demonstrated technical leadership, policy experience, and problem solving skills working on and providing expert oversight of complex projects in a highly sensitive environment.
- Excellent leadership, communications and interpersonal skills with the ability to work effectively with a broad range of USG personnel and partners, and in a team environment and communicate highly technical health information to both health and non-health audience.
- Demonstrated ability to work effectively with senior officials and other donors using tact and diplomacy to establish and develop sustainable working relationships at the highest level and a high level of trust with public/private partnerships.
- Excellent written communication skills to prepare regular and ad hoc reports, activity documentation and briefing papers.
- Knowledge of USAID programs, procedures, and systems for program design, procurement, logistics, management, and oversight, including up-to-date procurement practices in the Automated Directives System (ADS) and the Federal Acquisition Regulation (FAR) requirements preferred.
- Computer skills in MS Office, including Word, Excel, and Power Point.
- Willingness and ability to travel internationally.
- Knowledge of French desired.
- The selected candidate will be subject to a background investigation and must obtain and maintain a favorable adjudication as applicable to their position/duties.
About the Organization
Social Solutions International, Inc. (Social Solutions) is a Hispanic and woman-owned business emphasizing quality research and evaluation, training and technical assistance, and institutional support services. We are a mission-driven organization that believes that superior science can improve the world. Social Solutions is dedicated to the creation of social and health solutions to improve the welfare of underserved populations worldwide.
Social Solutions offers competitive salaries and comprehensive benefits.
Please submit your resume online at: https://jobs-socialsolutions.icims.com/jobs/1503/senior-quality-assurance-advisor%2c-malaria/job?mode=view
NOTE: In order to fully evaluate your eligibility, your resume must include relevant paid and non-paid work experience showing dates held with month and year and hours worked per week for each position. Any experience that does not include dates held and hours worked may not be counted.
Social Solutions is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, disability status, sexual orientation, gender identity or any other characteristic protected by law.
GHSI-III is a Federal services contract contingent on the availability of appropriated funds until the end of the designated contract period. Contract employees of GHSI-III are not U.S. Government employees and cannot perform Inherently Governmental Functions.