Laboratory Quality Officer

Position Description

The laboratory Quality Management Officer will lead, implement, maintain, and continuously improve the Quality Management System (QMS) at IGH in alignment with ISO/IEC 17025 requirements for testing and calibration laboratories. The role is critical to achieving and sustaining accreditation, ensuring technical competence, data integrity, regulatory compliance, and operational excellence across all IGH operations, including laboratory, human resources, IT, and facilities.

Main Duties/Key Responsibilities

Quality Management System (QMS)

• Develop, implement, and maintain the QMS in accordance with ISO/IEC 17025
• Ensure all policies, procedures, SOPs, and records comply with accreditation requirements
• Maintain the Quality Manual and document control system
• Coordinate management reviews and ensure follow-up of action items
• Promote a culture of quality, safety, and continuous improvement across IGH

Accreditation & Compliance

• Lead preparations for ISO 17025 accreditation audits (internal and external)
• Serve as primary liaison with accreditation bodies and regulatory agencies
• Monitor compliance with applicable standards, guidelines, and donor requirements
• Track corrective and preventive actions (CAPA) and ensure timely resolution
• Support validation and verification of methods, equipment, and processes

Internal Audits & Risk Management

• Plan and conduct internal audits of laboratory processes and systems
• Identify non-conformities, risks, and improvement opportunities
• Develop risk mitigation plans and monitor effectiveness
• Maintain audit schedules, reports, and compliance documentation

Documentation & Records Management

• Oversee document control, versioning, and record retention systems
• Ensure traceability of samples, reagents, equipment, and results
• Maintain training records, competency assessments, and quality logs

Training & Capacity Building

• Train staff on QMS procedures, ISO requirements, and quality practices
• Support competency assessment programs for laboratory personnel
• Provide guidance on good laboratory practices (GLP) and biosafety standards

Continuous Improvement & Data Quality

• Monitor quality indicators and performance metrics
• Investigate deviations, complaints, and incidents
• Lead root-cause analyses and improvement initiatives

Equipment & Process Oversight

• Support equipment calibration, maintenance, and qualification programs
• Ensure proper validation of new methods, instruments, and workflows
• Monitor environmental conditions impacting laboratory quality

Required Qualifications

Education

• Bachelor’s degree in Laboratory Science, Molecular Biology, Microbiology, Public Health, or related field
• Master’s degree preferred

Experience

• Minimum of 5 years’ experience in laboratory quality management or regulatory compliance
• Demonstrated experience with ISO/IEC 17025 or ISO/IEC 15189 (implementation, maintenance or audits)
• Experience in molecular diagnostics, genomics, or research laboratories strongly preferred
• Prior involvement in accreditation audits is highly desirable

Preferred Certifications

• ISO 17025 or ISO 15189 Lead Auditor or Internal Auditor certification
• Quality management certifications (e.g., CQI, ASQ)
• Training in GLP, biosafety, or regulatory compliance

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