Senior Malaria Quality Assurance/Quality Control Advisor

				Overview:

Summary Statement

Credence Management Solutions employs hard-working, passionate individuals who bring innovation, accountability, and a growth mindset to the many missions we support across the US Federal Government. Employee empowerment is part of the fabric of our corporate culture through which we emphasize opportunity, recognition, reward, and retention. At Credence, we follow the principles of servant leadership and believe that serving and supporting others is critical to both our individual and collective achievements. We have only one measure of success. Yours.

We are hiring for positions under the Global Health Training, Advisory, Support Contract (GHTASC) in support of the U.S. Agency for International Development (USAID) Bureau for Global Health (GH). These roles deliver institutional support services in a wide range of technical areas at the junior, mid-, senior, and expert levels. 

We are a diverse, enthusiastic family of subject matter experts, business professionals, and practitioners who all share a common goal of providing excellent services to our government customers. If you want to work in a dynamic and fast-growing environment with highly motivated colleagues, then Credence is the right place for you!

Credence Management Solutions is seeking a Senior Malaria Quality Assurance/Quality Control Advisor.  See below for more information on this exciting opportunity and apply to join Credence today!

Position Summary 

The Senior Malaria Quality Assurance/Quality Control Advisor will primarily support the ID/MAL as a Credence Institutional Support Contractor (ISC).

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.

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.

Responsibilities:

Senior Malaria Quality Assurance/Quality Control Advisor sits within the Malaria Supply Chain Branch and provides technical leadership and support of PMI's QA/QC activities. The Senior Advisor will support the work of PMI staff at USAID headquarters and at PMI country and regional mission programs. The Senior 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. 

The Senior Advisor will exercise independent judgment in planning and carrying out tasks. The Senior Advisor 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. 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. S/he will be an integral part of the Supply Chain team contributing to PMI's goals and targets related to malaria commodity purchase, coordination, and logistics and quality assurance of malaria commodities.

Technical leadership:

* 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 prequalification 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
			

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