Sue W

I’m a Quality Management Systems (QMS) and Regulatory Specialist with a 10-year career institutionalizing rigorous quality governance to safeguard medicine access across East Africa and global affiliates. I bridge global regulatory standards and local market reality through systemic risk mitigation and operational agility.

I’ve consistently delivered clean outcomes across national and international regulatory inspections, strengthened by proactive audit readiness programs and closed-loop CAPA systems. At MyMedGlobal, I directed QMS oversight for the global affiliate with a “Zero Major Finding” record, and I modernized deviation and CAPA workflows to clear backlogs and reduce time to close from years to under 90 days.

I also lead public-health focused quality initiatives aligned with WHO priorities—driving cold chain excellence, serialization, and market surveillance to secure a 300+ product supply chain. In regulatory work, I introduced structured regulatory risk assessment methodologies and supported market access for medical devices, including securing CE marking approvals for Class II devices.

Earlier in my career, I supported compliance and quality across multiple East African markets, including serving as Company Pharmacist for Roche’s Kenya and Diabetes portfolio. I’ve also built foundational expertise in dossier compilation, supplier qualification, cGMP documentation, and stability studies (ICH Zone II/IVb), grounding my approach in both regulatory rigor and practical execution.