Back Specialist, QA Market Surveillance & Vigilance - GL D - Temporary until December 2024

Specialist, QA Market Surveillance & Vigilance - GL D - Temporary until December 2024

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.

The Product & Supplier 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 procedure, governance model and case management. The Product & Supplier QA Compliance 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 Market Surveillance & Vigilance works under the supervision of the Manager, Product & Supplier QA Compliance.

The Specialist, QA Market Surveillance & Vigilance analyzes 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, the Specialist, QA Market Surveillance & Vigilance proposes, advises and supports the implementation market surveillance strategy and programs in line with the emerging risk identified.

The Specialist, QA Market Surveillance & Vigilance contributes to country regulatory strengthening activities on vigilance and post-market surveillance.

Key Responsibilities

Working under the supervision of the Manager, Product & Supplier QA Compliance, the Specialist, QA Market Surveillance & Vigilance will be responsible for:

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.

  Market Surveillance & Vigilance

  • Contribute to the technical support provided to countries in order to ensure implementation of TGF Market surveillance and vigilance activities.
  • 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 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 reports are reported to Global Fund QA .
  • Contribute to country strengthening activities on vigilance and post-market surveillance.
  • Contribute to the selection of service providers on Regulatory, Quality Assurance and quality control matters including market surveillance and vigilance.
  • Contribute to the coordination of product recalls with internal stakeholders and national regulatory bodies in case of non-compliance of healthcare products procured with Global Fund funds.

    Partnership

    • Support coordination and interaction across Supply Operations teams, for an aligned approach on Market surveillance and vigilance.
    • 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.
    • Contributes to strengthening collaboration and effective communication between the QA 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 and Head of Supply Operations 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

          📚 𝗗𝗶𝘀𝗰𝗼𝘃𝗲𝗿 𝗛𝗼𝘄 𝘁𝗼 𝗚𝗲𝘁 𝗮 𝗝𝗼𝗯 𝗶𝗻 𝘁𝗵𝗲 𝗨𝗡 𝗶𝗻 𝟮𝟬𝟮𝟯! 🌍🤝 𝗥𝗲𝗮𝗱 𝗼𝘂𝗿 𝗡𝗘𝗪 𝗥𝗲𝗰𝗿𝘂𝗶𝘁𝗺𝗲𝗻𝘁 𝗚𝘂𝗶𝗱𝗲 𝘁𝗼 𝘁𝗵𝗲 𝗨𝗡 𝟮𝟬𝟮𝟯 𝘄𝗶𝘁𝗵 𝘁𝗲𝘀𝘁 𝘀𝗮𝗺𝗽𝗹𝗲𝘀 𝗳𝗼𝗿 𝗨𝗡𝗛𝗖𝗥, 𝗪𝗙𝗣, 𝗨𝗡𝗜𝗖𝗘𝗙, 𝗨𝗡𝗗𝗦𝗦, 𝗨𝗡𝗙𝗣𝗔, 𝗜𝗢𝗠 𝗮𝗻𝗱 𝗼𝘁𝗵𝗲𝗿𝘀! 🌐

          ⚠️ 𝐂𝐡𝐚𝐧𝐠𝐞 𝐘𝐨𝐮𝐫 𝐋𝐢𝐟𝐞 𝐍𝐨𝐰: 𝐏𝐨𝐰𝐞𝐫𝐟𝐮𝐥 𝐓𝐞𝐜𝐡𝐧𝐢𝐪𝐮𝐞𝐬 𝐡𝐨𝐰 𝐭𝐨 𝐠𝐞𝐭 𝐚 𝐣𝐨𝐛 𝐢𝐧 𝐭𝐡𝐞 𝐔𝐧𝐢𝐭𝐞𝐝 𝐍𝐚𝐭𝐢𝐨𝐧𝐬 𝐍𝐎𝐖!

          Essential:

          • 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

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                  Job Posting End Date10 June 2024