Professional Experience:
Regional Quality Assurance and Regulatory Affairs Pharmacist with over 17 years of experience in the development, implementation, monitoring, assessment, and strengthening of health products quality affairs, policies and strategies, quality management systems, procurement activities and risk management frameworks for healthcare products and technologies across Africa.
Proven ability to analyze and localize global and regional regulatory and quality processes to ensure compliance with organizational and country-specific requirements.
Stakeholder liaison, navigating complex regulatory frameworks with various stakeholders including governments, regulatory agencies, local health authorities, and non-profit partners to gain organizational accreditation as a Humanitarian Purchasing Centre and Local Distributor (from ECHO, OFDA and MSF), facilitate product registrations/re-registrations, distribution, and safety reporting.
Effective communicator, fluent in English and Kiswahili with advanced use of MS Office Suite; solid knowledge of Good Manufacturing Processes, Good Storage Practices, and Good Distribution Practices.
CORE COMPETENCIES
Quality Assurance (QA) | Quality Management Systems (QMS) Developer | Quality Audits Expert | Pharmacovigilance | Regulatory Affairs | Medical Governance & Compliance | Risk Management | Team Leadership | Budget Management | Stakeholder Collaboration | Training/Capacity Building | Supply Chain |Medical Safety & Regulations | Quality Policy & SOPs Development | Product Registrations & Renewals