Clinical Quality & Compliance Manager (Medical Lab / Office Hours)

EnviroDynamics Solutions Pte Ltd; Singapore; Presencial; SGD 70.000 - 110.000; Jornada completa

Descripción de la vacante

EnviroDynamics Solutions Pte Ltd is seeking a Quality & Risk Lead for our Singapore North operations. You will drive QMS development, regulatory compliance, and audits across the lab network, ensuring data integrity and patient safety.

You will lead cross-functional teams, manage CAPA, and monitor KRIs and TAT, while mentoring staff and coordinating with stakeholders to advance quality and governance initiatives.

Formación

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

Responsabilidades

• Ensure compliance with regulatory and accreditation standards (ISO 15189, CAP, CLIA and MOH).
• Lead and coordinate internal, external and accreditation audits.
• Develop, implement and maintain the QMS with policies and SOPs.
• Monitor procedures and drive continuous quality improvement across lab operations.
• Manage quality incidents, complaints and non-conformances with RCA and CAPA.
• Monitor key quality indicators like TAT, error rates and specimen rejection.
• Support proficiency testing/EQAS activities and corrective actions.
• Identify and assess operational and strategic risks with mitigation plans.
• Develop KRIs and support ERM and IG activities.
• Conduct risk and governance audits and prepare risk assessments and reports.
• Collaborate with lab, clinical and corporate stakeholders to strengthen quality and risk.
• Lead and mentor team members across quality and risk initiatives.

Conocimientos

Quality management

Risk management

Audits coordination

Root Cause Analysis

Stakeholder coordination

Regulatory compliance

Quality improvement

Leadership

Problem solving

Educación

Degree in Medical Laboratory Science

Min. 2–5 years of experience in core laboratory with regulatory compliance, accreditation and QMS

Minimum 2 years of leadership experience

ASCP and/or ERM certification advantageous

Herramientas

Microsoft 365

IT applications

AI tools

Descripción del empleo

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