Laboratory Quality Assurance Manager

LABORATORY QUALITY ASSURANCE MANAGER

Organization: UNC Project Malawi

Location: Lilongwe

UNC Project Malawi, a renowned biomedical research, training, and service organization situated in Lilongwe, is seeking a highly qualified Laboratory Quality Assurance (QA) Manager to oversee its quality management systems.

Job Summary:

The Laboratory QA Manager will lead the development, implementation, and continuous enhancement of the laboratory's Quality Management System (QMS). This role provides independent oversight of quality assurance for research and laboratory operations, ensuring adherence to accreditation standards, Good Clinical Laboratory Practice (GCLP), regulatory requirements, study protocols, and UNC Project quality benchmarks. The QA Manager will collaborate closely with the Laboratory Director, Laboratory Manager, Research Laboratory Coordinator, supervisors, investigators, and external QA partners to maintain compliance and drive quality improvement initiatives.

Key Duties:

Administrative and Quality Management:

• Establish, implement, and maintain the Laboratory QMS in line with institutional, accreditation, regulatory, and research demands.


• Develop and execute an annual QA plan encompassing internal audits, quality reviews, improvement activities, and compliance monitoring.


• Prepare and present regular quality reports to laboratory leadership, detailing quality indicators, audit findings, CAPA status, QC trends, proficiency testing performance, and areas for improvement.


• Facilitate quality meetings, CAPA reviews, and quality improvement discussions, ensuring thorough documentation.


• Maintain open communication with laboratory leadership, research teams, investigators, collaborators, and external QA partners regarding quality matters.


• Coordinate preparation for laboratory assessments, audits, and inspections, including CAP, sponsor, DAIDS, and GCLP reviews.


• Oversee document control for SOPs, policies, forms, training materials, and quality records.


• Monitor the progress of assigned quality improvement activities and escalate unresolved issues.

Laboratory Assurance and Compliance:

• Conduct internal audits and monitoring to assess compliance with SOPs, study protocols, GCLP, and CAP standards.


• Manage non-conformance, including investigations, root cause analysis, CAPA implementation, and effectiveness monitoring.


• Review and monitor laboratory quality indicators, error trends, specimen management, turnaround times, and performance metrics.


• Provide recommendations for improving laboratory systems, mitigating risks, and enhancing operational efficiency.


• Oversee laboratory participation in proficiency testing programs and review performance outcomes.


• Ensure compliance with laboratory quality requirements across all research and clinical activities.

Training, Competency, and Technical Support:

• Ensure laboratory staff receive appropriate training and competency assessments.


• Review and maintain competency records and identify training needs.


• Support the quality oversight of new assays, instruments, methodologies, and research protocols.


• Provide guidance on troubleshooting quality issues and investigating errors or deviations.

Equipment and Laboratory System Oversight:

• Foster a culture of quality, safety, accountability, and continuous improvement within the laboratory.


• Ensure adherence to laboratory safety and biosafety procedures.


• Maintain strict confidentiality of all patient information, research data, and project operations.


• Cultivate effective working relationships with colleagues, collaborators, and external partners.


• Perform other duties as assigned by the Laboratory Director.

General Responsibilities:

• Demonstrate professional leadership and promote a culture of quality, safety, accountability, and continuous improvement.


• Ensure confidentiality of all sensitive information.


• Communicate and escalate quality risks and compliance concerns promptly to leadership.


• Support strategic planning, risk management, and continuous improvement initiatives.


• Promote teamwork and professional development.


• Utilize laboratory resources responsibly and support cost-effective practices.

Qualifications, Skills, and Experience:

• Bachelor’s degree in Medical Laboratory Technology, Biomedical Science, or a related field.


• Master’s degree in a scientific discipline or related field.


• Registered with the Medical Council of Malawi.


• Proficiency with Laboratory Information Systems (LIS) and Laboratory Data Management Systems (LDMS).


• A minimum of 5 years of experience in a laboratory setting.


• In-depth knowledge of laboratory equipment and procedures in a research environment.


• Ability to manage multiple tasks under pressure.


• Demonstrated experience in laboratory quality management systems, internal auditing, CAPA management, and continuous improvement.


• Experience with CAP, GCLP, DAIDS, and ISO 15189 quality systems.


• Strong understanding of laboratory documentation, competency assessment, proficiency testing, and regulatory compliance.


• Excellent written and verbal communication skills.


• Exceptional leadership, organizational, and problem-solving abilities.

To Apply:

Interested candidates should submit their applications via email to:

The Country Director
UNC Project
Lilongwe
Email: administration@unclilongwe.org

Application Deadline: Tuesday, August 11, 2026.

Only shortlisted candidates will be acknowledged.