Job Overview
About This Job in Kenya
This Director, Quality Assurance, Research & Regulatory Affairs position in Kenya offers professionals an opportunity to grow in the Healthcare & Medical sector. If you are searching for jobs in Kenya, this opportunity at KEMSA could be ideal for you.
The Director, Quality Assurance, Research & Regulatory Affairs at KEMSA provides strategic leadership for ensuring the quality, safety, and efficacy of health products and technologies (HPTs) procured and distributed by the Authority. Reporting directly to the Chief Executive Officer, the incumbent is responsible for developing, implementing, and monitoring policies, procedures, and systems that uphold the highest standards in quality assurance, research, and regulatory compliance. This senior leadership position ensures that all research initiatives and quality assurance processes are aligned with national and international standards, including ISO 9001:2015 and ISO 17025:2015 Quality Management Systems. The Director will oversee innovative research and development programs aimed at enhancing the safety, efficacy, and effectiveness of health products, ensuring findings are disseminated to relevant stakeholders to inform policy, procurement, and operational decisions. The role encompasses regulatory oversight, ensuring compliance with all applicable legislation, pharmacovigilance standards, and post-marketing surveillance requirements. This includes monitoring adverse events and product performance to ensure timely interventions where necessary. The Director will also establish and maintain robust quality assurance systems for testing, inspection, and evaluation of HPTs, ensuring that Good Distribution and Storage Practices are strictly adhered to across the Authority. Collaboration and stakeholder engagement are central to this role. The Director will maintain strong working relationships with regulatory authorities, government agencies, development partners, suppliers, and internal departments, fostering effective communication and collaboration. The role also requires strategic oversight of risk management for HPTs, ensuring potential hazards are identified, assessed, and mitigated proactively. In addition, the Director will provide leadership in human res…
Working as a Director, Quality Assurance, Research & Regulatory Affairs in Kenya
A career as a Director, Quality Assurance, Research & Regulatory Affairs in Kenya offers exciting opportunities for professionals looking to grow in the Senior / Management / Executive / Leadership sector.
Companies such as KEMSA are continuously searching for talented individuals who can contribute to innovation, productivity, and long-term business growth.
Professionals working in this field gain valuable experience, competitive career prospects, and opportunities to work with industry leaders across Kenya.
Why This Role Matters
This Director, Quality Assurance, Research & Regulatory Affairs role allows professionals to develop key skills in Healthcare & Medical. The position offers career growth opportunities while supporting the company's mission and values.
Responsibilities for Director, Quality Assurance, Research & Regulatory Affairs in Kenya
- Lead the development, implementation, and monitoring of research, quality assurance, and regulatory strategies, policies, procedures, and systems to ensure compliance with statutory and organizational requirements.
- Oversee research and development initiatives for innovative health products and advanced technologies, ensuring adherence to established quality, safety, and efficacy standards, and disseminate findings to relevant stakeholders.
- Ensure compliance with all applicable regulatory requirements, including pharmacovigilance, post-marketing surveillance, and reporting of adverse events.
- Establish, maintain, and continuously improve quality assurance systems for health products and technologies, including inspection, testing, and evaluation procedures.
- Oversee adherence to Good Distribution and Storage Practices, ensuring proper handling, storage, and transportation of all HPTs.
- Maintain and enforce compliance with ISO 9001:2015 and ISO 17025:2015 Quality Management Systems across the directorate.
- Coordinate with internal departments, regulatory authorities, suppliers, partners, and other stakeholders to ensure effective communication and collaboration in quality assurance and research activities.
- Implement risk management strategies for HPTs, identifying, assessing, and mitigating potential risks associated with product quality, safety, and supply chain operations.
- Develop and disseminate policies, guidelines, and standards for capacity building in research and quality assurance to enhance organizational capabilities.
- Lead budget planning and allocation for the directorate, ensuring optimal use of resources and alignment with organizational priorities.
- Set performance targets for all staff within the directorate, monitor achievement, and take corrective actions where necessary to ensure objectives are met.
- Monitor and evaluate key performance indicators for research, quality assurance, and regulatory functions, ensuring that high standards are consistently achieved.
- Provide career development, coaching, training, and skill-building opportunities for staff, fostering a culture of quality, accountability, and continuous improvement.
- Promote ethical practices, transparency, and good governance within the directorate and across the organization.
- Perform any other duties assigned within the scope of delegated authority, contributing to the overall mission and strategic objectives of KEMSA.
Qualifications for Director, Quality Assurance, Research & Regulatory Affairs in Kenya
- degree
Skills & Experience for Director, Quality Assurance, Research & Regulatory Affairs in Kenya
- Bachelor
- Master
- Membership in relevant professional bodies in good standing
- Registration with the appropriate regulatory professional body
- Certificate in management/leadership course of at least 4 weeks
- Proficiency in computer applications
- Demonstrated high degree of professional competence, managerial, and administrative capability
- Knowledge of national goals, policies, and quality assurance regulations
How to Apply for Director, Quality Assurance, Research & Regulatory Affairs in Kenya
Submit applications to Chief Executive Officer, Kenya Medical Supplies Authority, P.O BOX 47715-00100, Nairobi-Attn: Director, Corporate Services. Only shortlisted candidates will be contacted.
Frequently Asked Questions About the Director, Quality Assurance, Research & Regulatory Affairs Job in Kenya
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Is the Director, Quality Assurance, Research & Regulatory Affairs position at KEMSA still open?
Yes. Applications for this position are currently open. Interested candidates are encouraged to apply before the deadline. -
Does applying for this Director, Quality Assurance, Research & Regulatory Affairs job require any fees?
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How can I apply for this job at KEMSA?
Candidates can submit their application using the official application method provided in this job listing. Follow the instructions carefully to ensure your application for the Director, Quality Assurance, Research & Regulatory Affairs position is successfully submitted. -
Are there similar jobs available in Kenya?
Yes. JobVoro regularly publishes new vacancies across multiple industries. You can explore more opportunities in Kenya or browse other Senior / Management / Executive / Leadership jobs on our platform.
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