Quality & Compliance Lead – Lab Operations & Risk

ENVIRODYNAMICS SOLUTIONS PTE. LTD.; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd is seeking a Senior Quality & Risk Specialist to drive regulatory compliance, QA/QMS, and accreditation readiness across our laboratory operations in Singapore. You will lead audits, develop policies, and monitor KRIs with a focus on continuous improvement and risk mitigation.

The role requires a degree in Medical Laboratory Science, 2–5 years in a core lab, leadership experience, and familiarity with ISO 15189, CAP, CLIA, MOH standards; ASCP/ERM

Qualifications

• Degree in Medical Laboratory Science or related discipline.
• Min. 2-5 years of experience in a core laboratory focusing on regulatory compliance, accreditation and QMS.

Responsibilities

• Ensure compliance with regulatory and accreditation standards including ISO 15189, CAP, CLIA and MOH requirements.
• Lead and coordinate internal, external and accreditation audits, including audit preparation, findings management and follow-up.
• Develop, implement and maintain the Quality Management System (QMS), including policies, SOPs, manuals and document control.
• Monitor compliance with established procedures and drive continuous quality improvement across laboratory operations.
• Manage quality incidents, complaints and non-conformances, including Root Cause Analysis (RCA) and CAPA.
• Monitor key quality indicators such as turnaround time (TAT), error rates and specimen rejection rates, and lead improvement initiatives.
• Support proficiency testing / EQAS activities and monitor corrective actions arising from quality assessments.
• Identify and assess operational and strategic risks, developing appropriate mitigation and business continuity plans.
• Develop and monitor Key Risk Indicators (KRIs) and support Enterprise Risk Management (ERM) and Internal Governance (IG) activities.
• Conduct risk and governance audits and prepare risk assessments, management reports and stakeholder updates.
• Work closely with laboratory, clinical and corporate stakeholders to strengthen quality, risk management and regulatory compliance.
• Lead and mentor team members while driving quality and risk initiatives across functions.

Skills

Leadership

Regulatory compliance

Quality management

Audits

Risk management

Education

Degree in Medical Laboratory Science

Tools

Microsoft 365

IT applications

AI tools

Job description

EnviroDynamics Solutions Pte Ltd is seeking a Senior Quality & Risk Specialist to drive regulatory compliance, QA/QMS, and accreditation readiness across our laboratory operations in Singapore. You will lead audits, develop policies, and monitor KRIs with a focus on continuous improvement and risk mitigation.

The role requires a degree in Medical Laboratory Science, 2–5 years in a core lab, leadership experience, and familiarity with ISO 15189, CAP, CLIA, MOH standards; ASCP/ERM