Sr Medical Laboratory Scientist (Quality) - Contract

About the role

The NCIS Stem Cell Laboratory (SCL) processes, tests, stores, releases and distributes cellular therapy products for the Hematopoietic Cellular Therapy Transplant Program. The Senior Medical Laboratory Scientist (Quality) coordinates and oversees the Quality Management Program, ensuring compliance with HCSA Tissue Banking requirements and accreditation standards such as FACT-JACIE and AABB. The role provides independent oversight of quality management and reports performance, trends, risks and significant issues to facility leadership.

Key responsibilities

• Implement, maintain and continuously improve the Quality Management System (QMS)
• Ensure compliance with HCSA, FACT-JACIE, AABB and other accreditation and licensing requirements
• Monitor policy compliance and escalate quality concerns to the Facility Director and Medical Director
• Investigate, document, track and follow up deviations, non-conformances, complaints, adverse events and other quality occurrences
• Monitor corrective and preventive actions (CAPAs) and ensure timely closure of quality issues
• Prepare quality reports, management review materials and performance updates for leadership and committees
• Coordinate internal audits, regulatory inspections, accreditation assessments and quality reviews, and track findings
• Represent SCL on the institutional quality committee and liaise with internal and external stakeholders

Required profile

• BSc or other postgraduate qualification in health or biomedical sciences, with training and experience in quality management or cellular therapy
• Minimum of 5 years of quality management or relevant operational experience in a clinical laboratory, tissue banking, cellular therapy or related field preferred
• Experience with HCSA, FACT-JACIE, AABB or equivalent quality systems highly desirable
• Preferred: document control, change management, RCA, CAPA, risk management and audit/inspection experience
• Leadership experience of 3 years required

Required skills

• Analyse quality data, identify trends and drive improvement initiatives
• Proficiency in Microsoft Office and quality management documentation systems
• Good planning, communication and organisational skills; able to work independently