Pan-Africa Quality Assurance Audit and Certification Lead

About the role

Roche Diagnostics Africa is looking for a bilingual Pan‑Africa Quality Assurance Audit and Certification Lead to join the Africa Quality and Regulatory Chapter. Based in Nairobi, Accra or Cairo, you will oversee the Quality Management System across all African networks, ensuring compliance with global standards and local regulations.

Key responsibilities

• Design and execute a risk‑based annual internal and external audit strategy for all networks, distribution hubs and third‑party partners.
• Lead internal QMS audits against ISO 13485, ISO 9001 and local medical device/IVD regulations.
• Conduct audits and review documentation in both English and French.
• Manage external certification audits and regulatory inspections, acting as the primary regional contact.
• Track and validate CAPAs, partnering with local teams to ensure robust root‑cause analysis.
• Maintain existing certifications and prepare for expansion projects.
• Monitor African regulatory developments (e.g., SAHPRA, NAFDAC, EDA, TFDA, PPB) and align audit initiatives.
• Establish Quality KPIs, standardise cross‑border workflows and promote audit readiness through training.

Required profile

• ISO 13485 certified Lead Auditor with deep knowledge of medical devices and IVD regulations.
• Bilingual in English and French.
• Analytical thinker with diplomatic communication skills.
• Proven experience managing audits across multiple countries.

Required skills

• ISO 13485 audit methodology
• ISO 9001 compliance
• Medical devices regulatory knowledge
• In‑Vitro Diagnostics regulatory knowledge
• CAPA management
• Risk‑based audit planning