Director, Quality Assurance, Research & Regulatory Affairs at Kenya Medical Supplies Authority (KEMSA)

REF.KEMSA/HR/QAR&RA/03/2026, SA2, (1POST).

Reporting to the Chief Executive Officer.

PURPOSE STATEMENT;

• The purpose of this role is to provide strategic leadership in research, quality assurance, and regulatory affairs, ensuring compliance with standards, safety, and efficacy of health products and technologies, while fostering innovation, stakeholder collaboration, and continuous improvement in line with KEMSA’s mandate.

Duties and responsibilities will entail:

• Lead in development of Research and Quality Assurance strategies, policies, procedures and systems and ensure quality, safety and efficacy of HPTs procured by the Authority
• Lead and direct research and development initiatives for innovative health products and advanced technologies, ensuring adherence to quality and safety standard and disseminate the research report to the relevant stakeholders
• Oversee Compliance with relevant regulatory requirements
• Establish and maintain quality assurance systems tailored for health products and technologies (HPT), including testing, inspection, and evaluation procedures compliant with regulations.
• Oversee compliance to Good Distribution and storage Practice
• Implement pharmacovigilance and post-marketing surveillance strategies, ensuring adverse events and product performance are monitored effectively.
• Enforce compliance to quality standards and maintenance of ISO 9001:2015 and ISO 17025:2015 Quality Management systems (QMS)
• Coordinate with internal departments, regulatory bodies, partners, and stakeholders, fostering collaboration and effective communication.
• Oversee risk management for HPTs, identifying, assessing, and mitigating risks.
• Establish and maintain strong relationship with regulatory authorities, stakeholders and partners
• Develop, implement and disseminate policies guidelines and standards for HPTs capacity building
• Lead the development and coordination of the directorate’s budget.
• Set performance targets for all staff in the directorate and monitor performance
• Monitor and evaluate key performance indicators in HPTs, research and Quality Assurance to ensure that Quality of HPTs is achieved
• Provide career development, coaching, training and skill building for all staff in the research and Quality Assurance Directorate to meet both organizational and personal development goals and foster a culture of quality and continuous improvement.
• Carry out any other role as assigned in line with delegated authority matrix.

Requirements for Appointment

For appointment to this grade, an officer must have:

• Bachelor’s Degree in Pharmacy.
• Master’s Degree in any of the following disciplines; Pharmacy, Biochemistry, Biological Sciences, Chemistry, Nursing, Supply Chain Management or equivalent qualifications from a recognized institution.
• Cumulative service period of fifteen (15) years, five (5) of which should have been at the level of Deputy Director, Quality Assurance or in comparable position.
• Membership to relevant professional bodies and in good standing
• Registered as a relevant professional regulatory body under the relevant law.
• Certificate in management course lasting not less than four (4) weeks from a recognized institution
• Proficiency in computer applications;
• Demonstrated professional competence and ability as reflected in work performance and results; and
• Meet the provision of Chapter Six of Constitution.

OR

• Cumulative service period of fifteen (15) years, five (5) of which should have been at the level of Deputy Director, Quality Assurance or in a comparable position;
• Bachelors’ degree in Chemistry/ Biochemistry/Analytical Chemistry/Medical Laboratory/Microbiology or any other related field
• Master’s Degree in any of the following disciplines in Pharmacy/Chemistry/ Biochemistry/Analytical Chemistry/Medical Laboratory/Microbiology or any other related field
• Certificate in Leadership course lasting not less than four (4) weeks from a recognized institution;
• Proficiency in computer applications,
• Fulfilled the requirements of Chapter Six of the Constitution;
• Demonstrated a high degree of professional competence, managerial and administrative capability as reflected in work performance and results.
• Exhibited a thorough understanding of national goals, policies, and objectives, and the ability to relate them to the Quality Assurance function.