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 Fundโs investments is used to procure key health products, ensuring they are available to those who need them most.
The Global Fundโs 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 Fundโs 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 Fundโs NextGen Market Shaping Strategic Initiativeโs 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
- Contribute to the technical support provided to country, region and continental initiative in order to ensure implementation of robust regulatory system and quality assurance mechanism and in particular on registration, storage & distribution, market surveillance, quality control and testing and vigilance
- Contribute to the selection of service provider on Regulatory, Quality Assurance and quality control matters including testing
- Contribute to Global Fundโs Next Gen Market shaping approach and activities on regional manufacturing capacity building, from regulatory and quality assurance perspectives.
Coordination, Stakeholder and partnership management on regulatory matters
- Support coordination and interaction across Supply Operations teams, for an aligned approach on Regulatory strengthening and QA matters
- Support the implementation of the NextGen Market Shaping Strategic Initiativeโs work on regional manufacturing, particularly regulatory strengthening and harmonization
- Contribute in regular feedback sessions with WHO and other Partners to improve sharing of information on regulatory maturity
- Support partnership and coordination on regulatory and quality assurance matters for reliance, convergence, capacity building and regional harmonization
- Contribute to the development and implementation of QA management system that is well integrated with the Global Fundโs enterprise resource management ecosystem to enable advanced analytics, performance monitoring and KPI reporting.
Policy
- Contribute to the development and enhancement of Global Fundโs QA policies, guidelines and governance model
- Provide advice and support at all stages of grant design and implementation on in-country regulatory and QA matters
- Provide advice to internal stakeholders e.g. Direct Sourcing Team, Health Product Management Specialists on country QA maturity assessment, identification of system weaknesses and capacity gaps to inform country or region regulatory or QA enhancement plan
- Contribute to development of technical briefs or other supportive guidance document to help applicants prepare their funding requests.
Subject to change by the Executive Director at any time at their sole discretion.
Qualifications
Essential:
- Advanced university degree in health science such as Pharmacy, Chemical Engineering or an equivalent combination of academic/professional qualifications and experience within the area of health products regulation and quality assurance.
Desirable:
- Certification in regulatory affairs.
Experience
Essential:
- Working experience in QA management in the private or public sector
- Experience with QA regulatory policies and framework within global public health
- Experience with external partner engagement in a multilateral context, with e.g., UN agencies, International NGOs and Donors on QA issues
- Knowledge in developing QA related policies, tools, and guidance
- Experience in matrix organizations and working in cross-functional teams.
Desirable:
- Minimum 6 years working experience in QA management or regulatory affairs
- Work experience in a country supported by the Global Fund and/or other Partners in the same field of activities such as USAID.
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:
- Legal -1
- Geopolitical Awareness - 2
- Communications - 2
- Negotiations - 2
- Procurement and Supply Chain - 2
- Risk - 2
Other Competencies
- Able to work in diverse teams to lead and collaborate effectively in a complex, multi- disciplinary environment.
The Global Fund recruits top-tier talent for our open positions, in support of our mission to end AIDS, tuberculosis and malaria as epidemics.
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Explore our vacancies and apply on the Global Fund Careers recruitment system.
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More information on working at the Global Fund is available on the Careers section of our main website.
Job Posting End Date24 March 2024
- Able to work in diverse teams to lead and collaborate effectively in a complex, multi- disciplinary environment.
- Certification in regulatory affairs.
- Advanced university degree in health science such as Pharmacy, Chemical Engineering or an equivalent combination of academic/professional qualifications and experience within the area of health products regulation and quality assurance.