Specialist, QA Monitoring, Vigilance & Market Surveillance

Strengthens Global Fund surveillance and vigilance for the quality, safety and efficacy of procured health products. The specialist analyses quality signals, advises on risk mitigation, supports country regulatory capacity and market-surveillance programmes, manages product recalls, and helps embed quality-assurance governance, analytics and coordination across supply and partner networks.

• Develop and enhance Global Fund quality-assurance policies, guidance and governance
• Support countries to implement market-surveillance and vigilance activities
• Analyse quality, safety and efficacy signals and propose risk-mitigation strategies
• Assess risks to health-product quality and support country market-surveillance programmes
• Build country capacity through national vigilance systems, training and regulatory frameworks
• Lead investigations of quality complaints and safety events and advise on mitigation
• Coordinate product recalls with internal stakeholders and national regulatory bodies
• Contribute to quality-management systems, analytics, performance monitoring and partner coordination

• Advanced university degree in Pharmacy, Chemical Engineering or life science, or an equivalent combination of academic and professional qualifications and experience in Quality Assurance and Regulation
• Minimum five years of quality-assurance management experience in the private or public sector
• Experience in regulatory systems within global public health
• Experience developing and implementing market-surveillance strategies
• Experience engaging external partners on quality assurance in a multilateral context
• Excellent written and verbal English

• Project management, process improvement or organisational-change qualifications
• Certification in medical vigilance and pharmacoepidemiology
• Knowledge of ISO 13485, ISO 2859-1, ISO 2859-2 and ISO 17025
• At least 10 years of quality-assurance management or regulatory-affairs experience
• Good working knowledge of French

• Quality Assurance
• Market Surveillance
• Medical Vigilance
• Risk Assessment
• Product Recall Management
• Regulatory Strengthening
• Quality Incident Investigation
• Quality Management Systems
• Pharmacovigilance
• Partner Coordination

• ISO 13485
• ISO 2859-1
• ISO 2859-2
• ISO 17025