Specialist, QA Regulatory Harmonization & Regional Production Capacity - GL D - Temporary until December 2024 (Reposted)
The Global Fund aims to accelerate the end of AIDS, tuberculosis (TB) and malaria as epidemics. We invest more than US$4 billion a year to support programs run by local experts in countries and communities most in need. Since 2020, through the COVID-19 Response Mechanism (C19RM), additional funding has been made available to support countries to mitigate the impact of COVID-19.
As part of our mandate to fight the three diseases and increase access to quality-assured health products and services at affordable and sustainable prices, the Global Fund plays a leading role in global markets for medicines and technologies that prevent, diagnose, and treat HIV, Tuberculosis and Malaria. Every year, more than half of the Global Fund’s investments is used to procure key health products, ensuring they are available to those who need them most.
The Global Fund’s Supply Operations Department, in collaboration across the Global Fund Secretariat, is responsible for the overall management of sourcing, procurement, quality assurance and supply chain related matters, including strategy formulation and implementation, development of policy guidelines and ensure compliances, drive innovation, sustainability agenda and new product introduction, and importantly support country capacity building contributing to a more resilient and agile national health care supply chain.
To implement the Global Fund’s 2023-2028 Strategy, Supply Operations has recently introduced a new operating model, aiming to achieve accelerated value contributions to the communities and people we serve more effectively and efficiently.
The Quality Assurance (QA) & Compliance team plays a key function in ensuring safe access and delivery of quality assured health products to the communities and people we serve. This mission is implemented by enabling program and operational requirements, while mitigating residual risks associated with quality, safety and efficacy of health products procured with Global Fund funds through clearly established policies, governance model, case management and in-country support.
The Specialist, QA Regulatory harmonization & Regional production capacity works under the supervision of the Manager, QA Policy, Governance & Capacity-Building.
The Specialist, QA Regulatory harmonization & Regional production capacity provides support to the in-country implementation of TGF quality assurance and quality control requirements and in particular on registration, storage & distribution, market surveillance, quality control and testing and vigilance. This includes the selection of service providers on Regulatory, Quality Assurance and quality control matters including testing.
The Specialist further supports the Global Fund’s NextGen Market Shaping Strategic Initiative’s work on regional manufacturing to catalyze a stronger and more sustainable African manufacturing sector, particularly in matters related to regulatory strengthening, convergence & harmonization and capacity-building.
This further includes ensuring effective partnership with continental, regional and national regulatory authorities to support regional harmonization and country capacity building towards adoption and compliance with WHO and other internationally recognized standards on health products quality, safety and efficacy.
As such the Specialist, QA Regulatory harmonization & Regional production capacity contributes to building effective regulatory systems and processes which help support local production of health products. They provide advice to a range of internal stakeholders, including but not limited to Supply Operation teams, the Grant Management Division (GMD) and the Technical Advice and Partnerships (TAP) teams on country regulatory and Quality Assurance maturity assessment, identification of system weaknesses and capacity gaps to inform country enhancement plan.
Key Responsibilities
In-country Support & Regional Production Capacity-Building
Coordination, Stakeholder and partnership management on regulatory matters
Policy
Subject to change by the Executive Director at any time at their sole discretion.
Qualifications
Essential:
Desirable:
Experience
Essential:
Desirable:
Competencies
Languages:
An excellent knowledge of English and preferably a good working knowledge of French. Knowledge of other languages would be an asset [to be amended as per job requirements].
Functional Competencies:
Other Competencies
The Global Fund recruits top-tier talent for our open positions, in support of our mission to end AIDS, tuberculosis and malaria as epidemics.
Explore our vacancies and apply on the Global Fund Careers recruitment system.
More information on working at the Global Fund is available on the Careers section of our main website.
Job Posting End Date24 March 2024