Pan-Africa Quality Assurance Audit and Certification Lead

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The Position

Roche Diagnostics Africa is seeking a Bilingual Pan-Africa Quality Assurance Audit and Certification Lead to join them in either one of these locations: Nairobi, Accra or Cairo.

The Opportunity

As the Pan-Africa Quality Assurance Audit and Certification Lead, you play a vital role within the Africa Quality and Regulatory Chapter.

Operating within the highly regulated Medical Devices and In Vitro Diagnostics sector, you drive, govern, and maintain the Quality Management System (QMS) across all Sub-Region Africa networks to ensure compliance with global quality and ISO 13485 standards.

This opportunity is for an individual who is an analytical thinker with a diplomatic touch, who knows how to hold the line on compliance while maintaining excellent working relationships with local teams and external partners.

We are looking for an ISO 13485 certified Lead Auditor with a deep understanding of medical devices and In Vitro Diagnostics regulatory environments.
 

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 train...