Role Overview
The Director, Quality Assurance, Research & Regulatory Affairs is responsible for providing strategic leadership in research, quality assurance, and regulatory affairs at the Kenya Medical Supplies Authority (KEMSA). The role ensures compliance with standards, safety, and efficacy of health products and technologies (HPTs) while fostering innovation, stakeholder collaboration, and continuous improvement in line with KEMSA’s mandate.
Key Responsibilities
- Strategic Leadership: Lead the development of Research and Quality Assurance strategies, policies, and systems to ensure the quality and safety of HPTs procured by the Authority.
- Research & Development: Direct R&D initiatives for innovative health products and advanced technologies, ensuring adherence to standards and disseminating reports to stakeholders.
- Regulatory Oversight: Oversee compliance with relevant regulatory requirements and maintain Good Distribution and Storage Practices.
- Quality Management: Enforce compliance with quality standards and maintain ISO 9001:2015 and ISO 17025:2015 Quality Management systems (QMS).
- Systems Implementation: Establish quality assurance systems tailored for HPTs, including testing, inspection, and evaluation procedures.
- Monitoring & Safety: Implement pharmacovigilance and post-marketing surveillance strategies to monitor adverse events and product performance.
- Risk Management: Oversee risk assessment and mitigation for health products and technologies.
- Stakeholder Engagement: Coordinate with internal departments, regulatory bodies, and partners to foster effective communication and collaboration.
- Operational Management: Lead directorate budget coordination, set performance targets, and monitor key performance indicators.
- Staff Development: Provide coaching, training, and skill-building for directorate staff to foster a culture of quality.
Requirements for Appointment
Candidate Pathway 1:
- Bachelor’s Degree in Pharmacy.
- Master’s Degree in Pharmacy, Biochemistry, Biological Sciences, Chemistry, Nursing, Supply Chain Management, or an equivalent qualification.
- Minimum 15 years of cumulative service, with at least 5 years at the level of Deputy Director, Quality Assurance or a comparable senior position.
- Registration with and membership in good standing of a relevant professional regulatory body.
- Certificate in a management course (minimum 4 weeks).
Candidate Pathway 2:
- Bachelor’s degree in Chemistry, Biochemistry, Analytical Chemistry, Medical Laboratory, Microbiology, or a related field.
- Master’s Degree in Pharmacy, Chemistry, Biochemistry, Analytical Chemistry, Medical Laboratory, Microbiology, or a related field.
- Minimum 15 years of cumulative service, with at least 5 years at the level of Deputy Director, Quality Assurance or a comparable senior position.
- Certificate in a leadership course (minimum 4 weeks).
Common Requirements:
- Proficiency in computer applications.
- Demonstrated professional competence and managerial capability.
- Compliance with the provisions of Chapter Six of the Constitution of Kenya.
- Thorough understanding of national goals and policies related to the Quality Assurance function.
How to Apply
Interested candidates should submit their applications addressed to the address below. The deadline for applications is 22nd April, 2026 at 5:00 p.m. (East Africa Time).
Chief Executive Officer,
Kenya Medical Supplies Authority
P.O BOX 47715-00100, NAIROBI
Attn: Director, Corporate Services
Note: Only shortlisted candidates will be contacted for interviews.
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