Senior Advisor for Diagnostics Quality Assurance

The Global Health Fellows Program (GHFP-II) is a five year cooperative agreement implemented and managed by the Public Health Institute in partnership with Global Health Corps, GlobeMed, Management Systems International and PYXERA Global. GHFP-II is supported by the US Agency for International Development (USAID).

GHFP-II’s goal is to improve the effectiveness of USAID health programs by addressing the Agency’s immediate and emerging human capacity needs. The program seeks to accomplish this goal first through the recruitment, placement and support of diverse health professionals at the junior, mid and senior levels. These program participants include fellows, interns, corporate volunteers and Foreign Service National professionals. The program then provides substantial performance management and career development support to participants, including annual working planning assistance, and ensures that professional development opportunities are available.

Looking to the future, GHFP-II also seeks to establish a pool of highly-qualified global health professionals that will ensure the Agency’s ongoing technical leadership and effectiveness. This objective is supported by an extensive outreach program that brings global health opportunities and specialized career advice to a diverse range of interested individuals, with a particular focus on those underrepresented in the field of global health.

BACKGROUND:

The Office of HIV/AIDS (OHA) is the center of HIV/AIDS technical leadership for the Agency with primary responsibility for the Agency’s HIV/AIDS program. OHA provides strategic direction, technical leadership, and support to field programs in HIV and AIDS. It provides input to decisions concerning the strategic allocation of financial and human resources in the sector and assists in designing, implementing, monitoring, and evaluating programs. This entails:

· Ensuring the technical integrity of Agency and Mission strategies

· Providing global technical leadership on the full range of issues related to HIV/AIDS prevention, care, and treatment

· Managing numerous research and field support programs

· Monitoring and reporting on the impact of the Agency’s HIV/AIDS program

The Supply Chain for Health (SCH) Division provides strategic and technical leadership on supply chain issues to ensure adequate quantity and quality of essential commodities for people affected by HIV/AIDS and related infections. SCH is responsible for managing the largest public health supply chain in the world. Specifically, the Division is responsible for managing the following:

· Operating a sustainable central procurement operation and managing the supply chain for HIV/AIDS commodities. This includes procuring and distributing pharmaceuticals and other commodities needed to provide care and treatment of persons with HIV/AIDS and related infections

· Providing technical support and leadership to USAID Missions in strengthening partner country capacity to ensure a safe, secure, reliable, and sustainable supply chain system

· Providing technical assistance to support country and regional supply chain programs

· Coordinating with other US Government Agencies, international organizations, and donors to provide global leadership on supply chain issues

· Providing rapid response in emergency situations and potential stock-outs

· Managing the HIV/AIDS Working Capital Fund

· Maintaining the Agency Anti-retro viral (ARVs) and Rapid Test Kit (RTKs) approval lists

· Administering the “restricted commodities” approval of pharmaceuticals and “clearance” authority on source-origin waivers under ADS 310 and 312 for the Agency

INTRODUCTION:

The Senior Advisor for Diagnostics Quality Assurance (Senior Advisor) will be on the SCH team. SCH is responsible for a multi-billion dollar Global Health Commodity Program that procures ARVs, HIV RTKs, and other essential medicines and commodities for the inter-agency President's Emergency Plan For AIDS Relief (PEPFAR) and furnishes supply chain technical assistance. The Senior Advisor works with other Global Health offices, USAID Missions, CDC and other agencies both domestically and overseas, including the Office of the Global AIDS Coordinator, host country governments, international organizations, and private voluntary organizations, on a wide range of challenging and interesting issues. The Senior Advisor will receive day to day guidance from the Senior Medical Advisor.

ROLES AND RESPONSIBILITIES:

The Roles and Responsibilities of the Senior Advisor include the following, particularly as related to the scale-up, roll-out, and implementation of a quality assurance system for diagnostics primarily for HIV and related prevention and treatment:

· Serving as the subject matter expert within OHA, GH and USAID on diagnostic product quality assurance for HIV prevention and HIV-related programs.

· Advising senior USAID leadership in the development and implementation of short- and long-term program strategies to implement diagnostic product quality assurance.

· Developing a diagnostic product quality assurance strategy for USAID, primarily for HIV/AIDS and related treatment and care.

· Developing a regulatory framework for the quality assurance of diagnostic products and a site inspection framework for diagnostic manufacturers.

· Developing and supporting implementation plans and strategies in collaboration with the Global HIV Diagnostics Workgroup and other development partners, donors, beneficiaries and advocacy groups.

· Assisting in the introduction and implementation of HIV diagnostics, building on USAID experience with the introduction of other health technologies (e.g., contraceptives, vaccines, medical male circumcision, male and female condoms).

· Planning and supporting the development of strategic demand forecasts and marketing plans for diagnostics.

· Identifying priorities for product scale-up and roll-out through consultations with the public, academic, and private sectors.

· Identifying product manufacturing and distribution issues and defining alternative scenarios.

· Supporting implementation research to address key questions regarding diagnostics.

International travel approximately 20%

Training and professional development

· Keeping informed of diagnostic product quality assurance for HIV prevention, treatment and programming.

· Deepening knowledge of diagnostic product quality assurance for HIV prevention, treatment and programming.

· Participating in professional meetings as appropriate to SOW.

· Participating in professional continuing education and skills training within the purview of GHFP-II.

REQUIRED SKILLS, KNOWLEDGE & EXPERIENCE:

• Masters or higher level academic degree(s) or comparable experience in technical fields relevant to health product regulatory approval, manufacturing, scale-up, and roll-out.
• Minimum of ten (10) years of experience relevant to health technology introduction and implementation, and with at least three (3) years’ experience in an international or resource challenged setting.
• Experience or knowledge of health programs in developing country settings with limited resources and infrastructure.
• Demonstrated experience in applying intellectual rigor and good judgment in program evaluation and oversight.
• Excellent analytical skills.
• Excellent oral and written communication skills.
• Ability to work independently with minimal supervision.
• Ability to travel internationally and within developing country context.
• US citizenship required.

SALARY AND BENEFITS:

Salary based on commensurate experience and earnings history. The Public Health Institute offers a comprehensive benefits package including professional development programs.

How to apply:

All applicants are required to apply for this position through GHFP-II’s online recruitment system athttps://www.ghfp.net/recruitment/, which allows you to store your CV, profile and bio data form in our database. A separate cover letter describing your qualifications and experience, interest and familiarity with issues relating to this position, and how this position relates to your career goals is required for each application.All online applications must be submitted by August 6, 2014 by 5:00 pm Eastern time.

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