Specialist, QA Regulatory Harmonization, Regional Production & Capacity Building - GL D - Defin

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 Fund’s Next Gen Market shaping approach and activities on regional manufacturing capacity building, from regulatory and quality assurance perspectives.
• Contribute to Global Fund Regulatory Systems blueprint as sub-component of Next Gen Market shaping approach
• Support funding request review and improvement for strengthening country Regulatory & Quality assurance capacities

• Support coordination and interaction across Supply Operations teams, for an aligned approach on Regulatory strengthening and QA matters
• Support the implementation of the Next Gen Market Shaping Strategic Initiative’s 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 Fund’s enterprise resource management ecosystem to enable advanced analytics, performance monitoring and KPI reporting.

• Contribute to the development and enhancement of Global Fund’s 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. 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.

• 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.

• Certification in regulatory affairs

• 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.

• 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

An excellent knowledge of English and preferably a good working knowledge of French. Knowledge of other languages would be an asset.

• Legal
  -1
• Geopolitical Awareness - 2
• Communications - 2
• Negotiations - 2
• Procurement and Supply Chain - 2
• Risk – 2

• Able to work in diverse teams to lead and collaborate effectively in a complex, multi- disciplinary environment.

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05 February 2026