Pan-Africa Quality Assurance Audit and Certification Lead

About the role

The Pan‑Africa Quality Assurance Audit and Certification Lead will be a key member of Roche Diagnostics Africa’s Quality and Regulatory Chapter. Working across multiple African territories, you will ensure the Quality Management System complies with global standards and local regulations for medical devices and in‑vitro diagnostics.

Key responsibilities

• Design and execute a risk‑based annual internal and external audit programme for all networks, distribution hubs and critical third‑party partners.
• Lead internal QMS audits, assessing compliance with ISO 13485, ISO 9001 and local medical device regulations.
• Conduct audits and review documentation in both English and French, providing accurate interpretation of local operations.
• Manage external certification audits and regulatory inspections, acting as the primary regional contact.
• Track and validate Corrective and Preventive Actions (CAPAs) with local teams to ensure robust root‑cause analysis.
• Maintain existing certifications and prepare the region for expansion projects.
• Monitor evolving African regulatory landscapes (e.g., SAHPRA, NAFDAC, EDA, TFDA, PPB) and align audit activities accordingly.
• Establish and report Quality KPIs, offering data‑driven insights to leadership.
• Standardise cross‑border workflows for warehousing, cold‑chain logistics, distribution and post‑market surveillance.
• Promote a culture of audit readiness through training, workshops and mock simulations in English and French.

Required profile

• Analytical thinker with a diplomatic approach to maintaining compliance while fostering strong relationships.
• Bilingual proficiency in English and French.
• Proven experience as an ISO 13485 Lead Auditor within the medical devices or IVD sector.
• Deep understanding of African regulatory environments and quality standards.

Required skills

• ISO 13485
• ISO 9001
• Lead Auditor certification
• Risk‑based audit planning
• CAPA management
• Regulatory knowledge of SAHPRA, NAFDAC, EDA, TFDA, PPB