Quality Assurance Lead: Regulatory & Risk Oversight

EnviroDynamics Solutions Pte Ltd; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd in Singapore is seeking a Quality & Risk Manager to lead regulatory compliance, accreditation and QMS across the laboratory operations. You will coordinate internal and external audits, develop and maintain the QMS, monitor risk indicators and lead continuous quality improvement initiatives.

The role requires strong leadership, collaboration with clinical and corporate stakeholders, and a proactive approach to risk management.

Qualifications

• Degree in Medical Laboratory Science or a related discipline.
• Min. 2–5 years of experience in a core laboratory focusing on regulatory compliance, accreditation and QMS.
• Good understanding of Risk Management and Quality Management Systems (QMS).
• ASCP and/or ERM certification is an advantage.
• Proficient in Microsoft 365, IT applications and AI tools.
• Minimum 2 years of leadership experience.

Responsibilities

• Ensure compliance with regulatory and accreditation standards (ISO 15189, CAP, CLIA and MOH).
• Lead and coordinate audits and audit preparation.
• Develop, implement and maintain the QMS with policies and SOPs.
• Monitor procedures and drive continuous quality improvement.
• Manage quality incidents, CAPA and RCA.
• Monitor KRIs and support ERM and IG activities.
• Conduct risk and governance audits and report updates.
• Collaborate with stakeholders to strengthen quality and risk management.
• Lead and mentor team across functions.

Skills

Regulatory compliance

Quality management

Risk management

Leadership

Audits coordination

Stakeholder collaboration

Education

Degree in Medical Laboratory Science

ASCP certification (advantage)

ERM certification (advantage)

Tools

Microsoft 365

IT applications

AI tools

Job description

EnviroDynamics Solutions Pte Ltd in Singapore is seeking a Quality & Risk Manager to lead regulatory compliance, accreditation and QMS across the laboratory operations. You will coordinate internal and external audits, develop and maintain the QMS, monitor risk indicators and lead continuous quality improvement initiatives.

The role requires strong leadership, collaboration with clinical and corporate stakeholders, and a proactive approach to risk management.