Pan-Africa Quality Assurance Audit and Certification Lead at Roche Kenya

Key Challenges

• 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.

Who You Are as an Ideal Candidate

• We are seeking an experienced individual in leading audits within the medical device, diagnostics, or life sciences industries. You should have a track record of turning complex audit non-conformances into actionable, pragmatic business improvements. Preferably you are bilingual (English & French) and have strong communication skills with the ability to influence and collaborate across diverse cultures and geographies. You also need to have experience working within structured vendor or partner frameworks (like a BPMF). 

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).