Senior Quality Scientist, Stem Cell Lab & Compliance

National University Hospital; Singapore; On-site; SGD 120,000 - 170,000; Full time

Job summary

National University Hospital is seeking a Sr Medical Laboratory Scientist (Quality) to oversee the Quality Management System for the Stem Cell Laboratory, ensuring compliance with HCSA, FACT-JACIE and AABB standards. The role includes investigation of deviations, CAPA tracking, and reporting quality performance to leadership.

The candidate will coordinate audits and regulatory inspections, work with clinical and quality teams, and drive continual improvement to ensure patient safety and product

Qualifications

• Minimum 5 years of quality management or relevant operational experience in a clinical laboratory, tissue banking, cellular therapy or related field preferred.
• Experience with 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.
• Ability to analyse quality data, identify trends, and implement improvements.
• Strong planning, organizational, and communication skills.

Responsibilities

• Facilitate implementation and maintenance of the Quality Management System for SCL.
• Ensure compliance with HCSA, FACT-JACIE, AABB standards and other relevant licenses/certifications.
• Monitor adherence to policies, escalate issues to Facility Director and Medical Director.
• Lead investigations, documentation, tracking, trending, and follow-up of deviations and quality events.
• Oversee CAPAs, corrective actions, and timely closure of quality issues.
• Prepare and present quality reports and management reviews to leadership and committees.
• Coordinate internal audits, inspections, and accreditation assessments.
• Track audit findings and ensure timely corrective actions.
• Represent SCL on quality committees and liaise with stakeholders.
• Support communications of quality-related matters with internal and external parties.

Skills

Quality management

Regulatory compliance

CAPA & RCA

Audits & inspections

Data analysis

Planning & organization

Communication

Microsoft Office

Collaboration

Education

BSc or postgraduate qualification in health or biomedical sciences

Tools

QMS software

Job description

National University Hospital is seeking a Sr Medical Laboratory Scientist (Quality) to oversee the Quality Management System for the Stem Cell Laboratory, ensuring compliance with HCSA, FACT-JACIE and AABB standards. The role includes investigation of deviations, CAPA tracking, and reporting quality performance to leadership.

The candidate will coordinate audits and regulatory inspections, work with clinical and quality teams, and drive continual improvement to ensure patient safety and product