Specialist, QA Monitoring, Vigilance & Market Surveillance - GL D - Defined Duration until December 2028
theglobalfund · Geneva ·
- Category
- QA
Specialist, QA Monitoring, Vigilance & Market Surveillance - GL D - Defined Duration until December 2028The Global Fund aims to accelerate the end of AIDS, tuberculosis (TB) and malaria as epidemics. As part of our mandate to fight the three diseases, 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.
As one of the biggest health product procurement entities in the public sector, investing nearly US$3 billion in health products and equipment procurement, the Global Fund is uniquely placed to drive equitable access to quality-assured health products, services and innovations through its Supply Operations department.
Supply Operations, collaborating across the Global Fund Secretariat, is responsible for the Global Fund’s market shaping activities and the overall management of health product sourcing, procurement, quality assurance and supply chains.
The Quality Assurance & 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 procedure, governance model and case management. The team works with external technical partners to keep the organization abreast of evolving matters related to health products QA requirements and compliance across public health sector.
The Specialist, QA Monitoring, Vigilance & Market Surveillance works under the supervision of the Manager, Product & Supplier QA Compliance. The Specialist supports the Global Fund’s mission by ensuring robust market surveillance and vigilance approaches are in place to monitor the quality, safety and efficacy of health products throughout their lifecycle. They ensure timely and appropriate management of health product related incidents downstream (post-shipment), with the assistance of the Associate Specialist, QA Case Management.
They analyze data and trends on all types of quality or safety or efficacy/poor performance information signals which can be of interest to assess potential risk for the quality of health products procured with The Global fund funds.
Based on information gathered and data analysis implemented, they propose, advise and support the implementation of the market surveillance strategy and programs in line with the emerging risk identified.
They contribute to country regulatory strengthening activities on vigilance and market surveillance.
As one of the biggest health product procurement entities in the public sector, investing nearly US$3 billion in health products and equipment procurement, the Global Fund is uniquely placed to drive equitable access to quality-assured health products, services and innovations through its Supply Operations department.
Supply Operations, collaborating across the Global Fund Secretariat, is responsible for the Global Fund’s market shaping activities and the overall management of health product sourcing, procurement, quality assurance and supply chains.
The Quality Assurance & 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 procedure, governance model and case management. The team works with external technical partners to keep the organization abreast of evolving matters related to health products QA requirements and compliance across public health sector.
The Specialist, QA Monitoring, Vigilance & Market Surveillance works under the supervision of the Manager, Product & Supplier QA Compliance. The Specialist supports the Global Fund’s mission by ensuring robust market surveillance and vigilance approaches are in place to monitor the quality, safety and efficacy of health products throughout their lifecycle. They ensure timely and appropriate management of health product related incidents downstream (post-shipment), with the assistance of the Associate Specialist, QA Case Management.
They analyze data and trends on all types of quality or safety or efficacy/poor performance information signals which can be of interest to assess potential risk for the quality of health products procured with The Global fund funds.
Based on information gathered and data analysis implemented, they propose, advise and support the implementation of the market surveillance strategy and programs in line with the emerging risk identified.
They contribute to country regulatory strengthening activities on vigilance and market surveillance.
Key Responsibilities
Policy and guidance
- Contribute to the development and enhancement of The Global Fund’s (TGF) QA policies, guidelines and governance model.
- Provide advice and support at all stages of grant design and implementation.
- Contribute to the development of technical brief(s) or other supportive guidance documents to help applicants prepare their funding requests.
QA Monitoring, Market Surveillance & Vigilance
- Contribute to the technical support provided to countries in order to ensure implementation of TGF Market surveillance and vigilance activities.
- Support QA compliance monitoring activities by linking vigilance findings with broader product quality assurance efforts, including supplier and PSA compliance verification.
- Working closely with the Associate Specialist, QA Case Management, lead the analysis of quality and safety signals, and contribute to risk mitigation strategies in collaboration with country teams and the QA & Compliance team.
- Analyze data and potential trend on all types of quality or safety or efficacy/poor performance signals.
- Contribute to the assessment of potential risk for the quality of health products procured with TGF funds in close collaboration with the relevant health product QA Specialist.
- Propose, advise and support implementation of market surveillance strategy and programs in countries in line with the emerging risk(s) identified and ensuring market surveillance activities or safety events are reported to Global Fund QA.
- Contribute to country capacity building by supporting the development of national vigilance systems, training programs, and regulatory frameworks for market surveillance.
- Contribute to the selection of service providers on Regulatory, Quality Assurance and quality control matters including market surveillance and vigilance.
- They lead the investigations of quality complaints, safety events and other quality challenges experienced by Global Fund Principal Recipients and advise QA Team Lead on optimal risk-mitigation measures
- Coordinate the product recalls with internal stakeholders and national regulatory bodies in case of non-compliance of healthcare products procured with Global Fund funds.
- They contribute to the assessments of country risk for downstream QA-related processes, and advise and support relevant in-country risk mitigation measures
Partnership
- Support coordination and interaction across Supply Operations teams, for an aligned approach on Market surveillance and vigilance.
- Collaborate with Technical Advice and Partnerships (TAP), Risk, and Grant Management divisions to ensure alignment of vigilance and market surveillance activities with grant implementation and risk mitigation strategies.
- Contribute to regular feedback sessions with WHO and other Partners to improve sharing of information on Market surveillance and vigilance.
- Support partnership and coordination on Market surveillance and vigilance.
- 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 strengthening collaboration and effective communication between the QA & Compliance team, other teams within Supply Operations and teams in other Global Fund divisions / departments such as Grant Management, Technical Advice and Partnerships (TAP) and Risk on shared priority initiatives and activities.
Subject to change by the Executive Director at any time at their sole discretion.
Qualifications
Essential:
- Advanced university degree in Pharmacy, Chemical Engineering, and/or life science or an equivalent combination of academic/professional qualifications and experience within the area of Quality Assurance & Regulation.
Desirable:
- Project management, process improvement or organizational change qualifications
- Certification in medical vigilance and pharmacoepidemiology
- Knowledge in ISO 13485, 2859-1 &-2, 17025.
Experience
Essential:
- Leadership and People management
- Minimum 5 years working experience in QA management in the private or public sector.
- Experience within regulatory system within global public health.
- Experience with external partner engagement in a multilateral context, with e.g., UN agencies, International NGOs and Donors on QA matters.
- Work experience in developing and implementing Market surveillance strategies.
- Work experience with a major multilateral organization.
- Experience in matrix organizations and working in cross-functional teams.
Desirable:
- Minimum 10 years of working experience in QA management or regulatory affairs.
Competencies
Languages:
An excellent knowledge of English and preferably a good working knowledge of French. Knowledge of other languages would be an asset.
Functional Competencies:
- Legal-Lev1
- Geopolitical Awareness-Lev2
- Communications- Lev2
- Negotiation -Lev2
- Procurement and Supply Chain- Lev2
- Risk -Lev2
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 Date
16 September 2026