Laboratory Compliance & Risk Manager (5 days / Office Hours)

EnviroDynamics Solutions Pte Ltd; Singapore; On-site; SGD 72,000 - 108,000; Full time

Job summary

EnviroDynamics Solutions Pte Ltd in Singapore seeks a Quality & Risk Lead to uphold regulatory compliance, accreditation standards, and a robust QMS across laboratory operations. You will coordinate audits, implement policies, manage incidents, monitor KPIs, and drive continuous quality improvement while collaborating with stakeholders.

The role requires a degree in Medical Laboratory Science, 2–5 years in a core lab, leadership experience, and familiarity with risk management and QMS; ASCP/ERM

Qualifications

• Degree in Medical Laboratory Science or related discipline.
• 2–5 years of experience in a core laboratory environment focusing on regulatory compliance and QMS.
• Good understanding of risk management and QMS.

Responsibilities

• Ensure compliance with regulatory and accreditation standards (ISO 15189, CAP, CLIA, MOH).
• Lead and coordinate internal, external and accreditation audits, including preparation and follow-up.
• Develop, implement and maintain the Quality Management System (QMS) including policies and SOPs.
• Monitor compliance and drive continuous quality improvement across laboratory operations.
• Manage quality incidents, complaints and non-conformances including RCA and CAPA.
• Monitor quality indicators and lead improvement initiatives.
• Support proficiency testing / EQAS activities and corrective actions.
• Identify and assess operational and strategic risks; develop mitigation and continuity plans.
• Develop and monitor KRIs and support ERM and IG activities.
• Conduct risk and governance audits and prepare management reports.

Skills

Quality management

Risk management

Audits

Leadership

Education

Bachelor's degree in Medical Laboratory Science

Tools

Microsoft 365

IT tools

AI tools

Job description

Company Profile

Join one of Singapore’s leading academic health systems, recognised for its excellence in healthcare, research, and education. The organisation has been ranked among The Straits Times’ Best Employers and listed in the Top 10 of Singapore’s Leading Employer Awards, reflecting its strong commitment to employee growth and engagement.

With a people-first culture, they are dedicated to staff development and workplace well-being. You can look forward to a meaningful career with an organisation that values innovation, compassion, and excellence in advancing health for the community.

Work location: North

Working hours: Monday to Friday, 8.30am to 6pm

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 Corrective and Preventive Actions (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.

Requirements:

• Degree in Medical Laboratory Science or a related discipline.
• Min. 2–5 years of experience in a core laboratory environment focusing on laboratory regulatory compliance, accreditation and Quality Management Systems (QMS) within a public or private healthcare institution.
• Good understanding of Risk Management and Quality Management Systems (QMS).
• American Society for Clinical Pathology (ASCP) and/or Enterprise Risk Management (ERM) certification is an advantage.
• Proficient in Microsoft 365, IT applications and AI tools.
• Minimum 2 years of leadership experience, with demonstrated ability to lead teams and cross-functional quality and risk initiatives.

Celine Chan I Reg. No: R21103433

EnviroDynamics Solutions Pte Ltd I EA License No.: 12C6285