OVERVIEW

UNC Project Malawi, a biomedical research, training and service organization based in Lilongwe, invites applications from suitably qualified and experienced individuals for the position of Laboratory Quality Assurance Manager.

The Laboratory Quality Assurance (QA) Manager is responsible for leading the implementation, monitoring, and continuous improvement of the laboratory Quality Management System (QMS). The position provides independent oversight of quality assurance activities across research and laboratory operations to ensure compliance with accreditation requirements, Good Clinical Laboratory Practice (GCLP), regulatory requirements, study protocols, and UNC Project quality standards. The QA Manager works closely with the Laboratory Director, Laboratory Manager, Research Laboratory Coordinator, Laboratory section supervisors, investigators, and external QA partners to ensure effective implementation of quality systems, continuous improvement initiatives, and maintenance of laboratory compliance.

KEY RESPONSIBILITIES

Administrative and Quality Management

• Develop, implement, and maintain the Laboratory Quality Management System in accordance with institutional, accreditation, regulatory, and research requirements.
• Develop and maintain an annual quality assurance plan, including internal audits, quality reviews, quality improvement activities, and compliance monitoring.
• Prepare and provide regular quality reports to the Laboratory Director and laboratory leadership, including quality indicators, audit findings, CAPA status, QC trends, proficiency testing performance, and areas requiring improvement.
• Coordinate quality meetings, CAPA reviews, and quality improvement discussions, ensuring documentation of decisions and follow-up actions.
• Maintain effective communication with laboratory leadership, research teams, investigators, collaborators, and external QA partners regarding quality activities and risks.
• Coordinate preparation for Laboratory assessments, audits, and inspections, including CAP accreditation assessments, sponsor audits, DAIDS reviews, and GCLP evaluations.
• Ensure effective document control systems are maintained for SOPs, policies, forms, training materials, and quality records.
• Monitor implementation and completion of assigned quality improvement activities and escalate unresolved quality issues to the Laboratory Director.

Laboratory Assurance and Compliance

• Conduct and coordinate internal audits and Laboratory monitoring activities to assess compliance with SOPs, study protocols, GCLP requirements, and CAP accreditation standards.
• Oversee laboratory non-conformance management, including investigation, root cause analysis, corrective and preventive actions (CAPA), and effectiveness monitoring.
• Review and monitor laboratory quality indicators, error trends, specimen management issues, turnaround times, and performance metrics.
• Provide recommendations to improve Laboratory systems, reduce risks, and strengthen operational effectiveness.
• Ensure laboratory participation in proficiency testing/external quality assessment programs and oversee review of performance and corrective actions.
• Monitor compliance with laboratory quality requirements across research and clinical laboratory activities.

Training, Competency and Technical Support

• Ensure laboratory staff receive appropriate training, competency assessments, and ongoing education.
• Review and maintain competency assessment records and identify quality-related training needs.
• Support implementation and quality oversight of new assays, instruments, methodologies, and research protocols.
• Provide guidance in troubleshooting Laboratory quality issues and support investigations of errors, deviations, and non-conformances.

Equipment and Laboratory System Oversight

• Promote a culture of quality, safety, accountability, and continuous improvement within the laboratory.
• Ensure compliance with Laboratory safety procedures, biosafety requirements, and occupational health standards.
• Maintain confidentiality of patient information, research data, laboratory results, and project operations.
• Maintain effective working relationships with colleagues, collaborators, investigators, and external partners.

General Responsibilities

• Demonstrates professional leadership and promotes a culture of quality, safety, accountability, and continuous improvement within the Laboratory.
• Ensures confidentiality of patient information, research data, laboratory results, and institutional information.
• Provides timely communication and escalation of quality risks, compliance concerns, and significant Laboratory events to Laboratory leadership.
• Supports strategic planning, risk management, and continuous improvement initiatives within the Laboratory.
• Promotes teamwork, professional development, and a positive working environment among Laboratory personnel.
• Uses Laboratory resources, equipment, and supplies responsibly and supports cost-effective quality improvement practices.
• Performs other duties as assigned by the Laboratory Director.

KEY REQUIREMENTS

• Bachelor's degree in Medical Laboratory Technology, Biomedical Science, or a related field, and a Master's degree in a scientific discipline or related field.
• Registered with Medical Council of Malawi.
• Proficiency with Laboratory Information Systems (LIS) and Laboratory Data Management System (LDMS).
• Minimum of 5 years' experience in a Laboratory setting.
• In-depth knowledge of Laboratory equipment and procedures in a research setting.
• Ability to work under pressure and manage multiple tasks simultaneously.
• Demonstrated experience in Laboratory quality management systems, internal auditing, CAPA management, and continuous improvement.
• Experience with CAP, GCLP, DAIDS, ISO 15189 quality systems.
• Strong knowledge of Laboratory documentation, competency assessment, proficiency testing, and regulatory compliance.
• Excellent written and verbal communication skills.
• Excellent leadership, communication, organizational, and problem-solving skills.

HOW TO APPLY

Please send your applications via email to:

Email: administration@unclilongwe.org

Application Deadline: Tuesday, 11th August 2026

Only shortlisted candidates will be acknowledged.