We are representing our Biotech client who is in the business of diagnostics tools. With Headquarter in Singapore, they are one of the largest NGS service providers in Southeast Asia.

Lab Quality Management Specialist

Responsibilities:

Technical Operations & Laboratory Management

• Support the management team in overseeing the planning, development, and execution of laboratory operations.
• Develop and implement policies and Standard Operating Procedures (SOPs) to ensure operational efficiency.
• Ensure laboratory instruments and equipment are properly validated, calibrated, and maintained in compliance with College of American Pathologists (CAP), ISO 15189, and MOH regulatory standards.
• Oversee the development, validation, and implementation of new lab tests, ensuring alignment with other relevant guidelines.
• Continuously improve existing laboratory processes and methods, providing training and knowledge transfer to technical staff.
• Evaluate laboratory infrastructure and equipment, making recommendations for enhancements to improve efficiency and capacity.
• Ensure laboratory safety and compliance with biosafety regulations and industry-standard health and safety protocols.
• Assist the technical team in the development, validation and implementation of novel scientific and clinical tests.
• Ensure the handling of clinical test specimens are in accordance to protocol
• Perform experiments on incoming projects to the laboratory and submit samples for downstream processing

Quality Assurance & Compliance

• Develop, implement, and maintain a comprehensive Laboratory Quality Management System (QMS).
• Lead internal and external audits, ensuring compliance with CAP, ISO 15189, MOH, and other accrediting bodies.
• Act as the Management Representative for quality certifications, coordinating audits and enforcing regulatory requirements.
• Establish and monitor Quality Control (QC) and Quality Assurance (QA) programs, ensuring continuous quality improvement.
• Champion the use of statistical and quality management tools to enhance laboratory performance and accuracy.
• Conduct inter-departmental quality audits, assess client quality requirements, and implement corrective and preventive actions (CAPA).
• Drive continuous improvement initiatives to optimize test turnaround time (TAT) and operational efficiency.

Risk Management & Resource Planning

• Develop and implement risk management strategies to ensure laboratory compliance with regulatory and accreditation requirements.
• Oversee procurement, supply chain, and logistics for laboratory materials, ensuring cost efficiency and operational continuity.
• Ensure the laboratory is audit-ready at all times for regulatory inspections, licensing renewals, and accreditation assessments.

Requirements:

• Master's degree or PHD in life sciences or biotechnology disciplines.
• Minimum 5 years of experience in a clinical diagnostic laboratory with a focus on molecular or microbiology disciplines.
• At least 3 years of experience in quality assurance/management.
• Hands-on experience in a CAP/ISO 15189-accredited medical laboratory setting.
• Strong background in laboratory safety practices, particularly BSL-2+ environments.
• Proven ability to lead teams, implement quality management methods, and oversee laboratory workflows.
• Experience in auditing, compliance, and risk management in a laboratory setting.
• In-depth knowledge of industry standards (CAP, ISO 15189, HSCA, MOH).
• Strong technical expertise in molecular diagnostic techniques and laboratory best practices.
• Excellent decision-making, problem-solving, and project management skills.
• Ability to thrive in a fast-paced, high-throughput laboratory environment.
• Effective communication, leadership, and team collaboration skills.

EA License No: 12C6254

EA Personnel Registration No: R1106329