Sr Medical Laboratory Scientist (Quality), NCIS - Contract(10555)

Overview and purpose of the position*
The NCIS Stem Cell Laboratory (SCL) supports the processing, testing, storage, release, and distribution of cellular therapy products for the Hematopoietic Cellular Therapy Transplant Program.
The Sr Medical Laboratory Scientist (Quality) is responsible for coordinating and overseeing the implementation, maintenance, and continual improvement of SCL’s Quality Management Program, ensuring compliance with HCSA Tissue Banking requirements and accreditation standards, including FACT-JACIE and AABB. The role provides independent oversight of quality management activities and reports quality performance, trends, risks, and significant quality issues to the facility leadership for review, escalation, and appropriate action. In addition, the Sr Medical Laboratory Scientist (Quality) will facilitate the investigation, documentation, tracking, trending, and follow-up of deviations, non-conformances, complaints, adverse events, and other quality occurrences affecting SCL activities.The Sr Medical Laboratory Scientist (Quality) will work closely with laboratory personnel, clinicians, quality teams, and external regulatory and accreditation bodies to ensure the highest standards of patient safety, product quality, and operational excellence.

Primary Responsibilities and Duties (80%)

General
•Facilitate the implementation, maintenance and continuous improvement of the Quality Management System (QMS) for SCL.
• Ensure compliance with Healthcare Services Act (HCSA), FACT-JACIE Standards, AABB Standards, and other applicable accreditation, licenses and certifications.
• Monitor compliance with policies and Standard Operating Policies, and where necessary escalate quality related concerns to the Facility Director and Medical Director.
• Facilitate the investigation, documentation, tracking, trending, and follow-up of deviations, non-conformances, complaints, adverse events, and other quality occurrences affecting SCL activities.
• Monitor the implementation and effectiveness of corrective and preventive actions (CAPAs) and ensure timely resolution and closure of quality issues.
• Prepare and present quality reports, management review materials, and quality performance updates to laboratory leadership and relevant committees.
• Coordinate internal audits, regulatory inspections, accreditation assessments, and quality reviews.
• Monitor and track audit findings and inspection observations to ensure timely corrective actions and sustained compliance.
• Represent SCL on institutional quality committee to facilitate the reporting, review, and follow-up of quality management activities relevant to SCL.
• Facilitate communication and follow-up of quality-related matters with internal and external stakeholders.

Secondary Responsibilities and Duties (20%)

• Any other duties as required by the Reporting Officer

Qualification Required and Area of Discipline

BSc or other postgraduate qualification in the field of health or biomedical sciences or related fields with training and experience in either quality management or cellular therapy. Required Competencies and Capabilities (Skills, Experiences and Professional Licences)
• 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 accreditation standards such as HSCA, FACT-JACIE, AABB or equivalent quality systems is highly desirable.
• Experience in document control, change management, RCA and CAPA, risk management, and audits / inspections is preferred.
• Demonstrated ability to analyse quality data, identify trends, and implement effective improvement initiatives.
• Good planning and organizing skills.
• Good communication and interpersonal skills.
• Proficient in Microsoft Office applications and quality management documentation systems.
• Proactive, self-motivated, attention to detail and solutions oriented. Ability to work independently while fostering collaboration across teams.

Required Leadership Required leadership experience: 3 Years