Senior Quality Scientist, Cellular Therapy Lab

National University Polyclinics; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

National University Hospital seeks a Sr Medical Laboratory Scientist (Quality) to coordinate and oversee the Quality Management System for the NCIS Stem Cell Laboratory. You will ensure compliance with HCSA, FACT-JACIE, and AABB standards while reporting quality performance to facility leadership.

You will investigate deviations, track trends, and drive CAPA, audits, and regulatory inspections with cross-functional teams to uphold patient safety and product quality.

Qualifications

• Minimum 5 years of quality management or relevant operational experience in a clinical laboratory, tissue banking, cellular therapy or related field.
• 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 improvement initiatives.
• Good planning, organizing, and communication skills.

Responsibilities

• Coordinate and oversee the implementation, maintenance and continuous improvement of the Quality Management System for SCL.
• Ensure compliance with HCSA, FACT-JACIE, AABB standards, and other applicable accreditation and licenses.
• Monitor CAPAs, deviations, non-conformances, complaints, adverse events, and quality issues; drive timely corrective actions.
• Prepare quality reports and management review materials for leadership and committees.
• Lead internal audits, regulatory inspections and quality reviews; liaise with stakeholders.

Skills

Quality management

Data analysis

Documentation

CAPA

Audits

Education

BSc in health/biomedical sciences

Postgraduate qualification

Tools

MS Office

QMS software

Job description

National University Hospital seeks a Sr Medical Laboratory Scientist (Quality) to coordinate and oversee the Quality Management System for the NCIS Stem Cell Laboratory. You will ensure compliance with HCSA, FACT-JACIE, and AABB standards while reporting quality performance to facility leadership.

You will investigate deviations, track trends, and drive CAPA, audits, and regulatory inspections with cross-functional teams to uphold patient safety and product quality.