Pan-Africa Quality Assurance Audit and Certification Lead

Your qualifications include:

• Education: Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Quality Management, or a related technical discipline.
  
• Certifications: Certified Lead Auditor for ISO 13485 and ISO 9001 (e.g., IRCA registered) is mandatory.
  
• Language Capabilities: Professional fluency in both English and French is desired. You are fully confident in auditing, writing technical reports, and communicating with regulatory authorities in both languages.
  
• Experience: 7-10 years of experience in Quality Assurance/Compliance within the Medical Devices or In Vitro Diagnostics industry.
  
• Regional Auditing: Proven experience managing or executing multi-country regional audit programs, ideally spanning both Anglophone and Francophone Africa.
  
• Operations Knowledge: Strong operational understanding of hub-and-spoke distribution models, cold chain requirements for diagnostics, and post-market surveillance.
  
• Regulatory Interaction: Prior experience interacting with Notified Bodies and National Regulatory Authorities across key African markets.
  
• Mobility: Willingness to travel regionally up to 30% (optimized through a hybrid remote/on-site assessment model).
  

• Design and execute a risk-based annual internal and external audit strategy for all networks, distribution hubs, and critical third-party partners across Africa.
  
• Lead as the principal auditor for internal quality management system audits, evaluating compliance against ISO 13485, ISO 9001, and local medical devices and In Vitro Diagnostics regulations.
  
• Conduct audits and review documentation seamlessly in both English and French, ensuring accurate interpretation of local operations across African territories.
  
• Manage external certification audits and regulatory inspections across the region, serving as the primary point of contact and host for the regional chapter.
  
• Track and validate Corrective and Preventive Actions (CAPAs), partnering with local teams to ensure root-cause analyses are robust and effective.
  
• Safeguard existing certifications and lead compliance readiness for expansion projects across Africa.
  
• Monitor the evolving regulatory landscape in Africa (including regulatory bodies like SAHPRA, NAFDAC, EDA, TFDA, and PPB) to proactively align audit initiatives with changing laws.
  
• Establish and monitor Quality Key Performance Indicators (KPIs) across regional networks, providing data-driven insights to the Q&R Chapter leadership.
  
• Standardize cross-border workflows, including warehousing, cold chain diagnostics logistics, distribution, and post-market surveillance.
  
• Foster an ongoing culture of audit readiness through targeted training, workshops, and mock simulations delivered in preferably both English and French.