Head of Quality Assurance – Healthcare

About the role

The Quality Assurance Head establishes and leads Asiatic Diagnostics' (Personal Collection's healthcare arm) enterprise quality management system and provides independent assurance that clinical, operational, patient‑facing, and support processes are designed, implemented, monitored, and improved in accordance with law, regulatory requirements, approved policies, and applicable quality standards. The role protects patient safety and result reliability by maintaining the quality framework, testing conformance, driving effective corrective action, and reporting material quality risks without interference.

Key responsibilities

• Lead and continuously improve the organization’s Quality Management System across laboratory, branch, home service, patient‑facing, and support operations.
• Drive ISO 15189 and ISO 9001 readiness, regulatory compliance, accreditation, licensing, and external assessments.
• Develop and execute risk‑based quality audits across sites, systems, suppliers, records, and business processes.
• Manage quality incidents, nonconformities, near misses, and CAPA, ensuring effective root‑cause analysis and sustainable corrective actions.
• Oversee quality documentation, records, and change control, ensuring policies and procedures remain current, compliant, and properly implemented.
• Establish and monitor quality KPIs and dashboards, identifying trends, risks, recurring issues, and improvement opportunities.
• Facilitate quality management reviews with senior leadership and drive accountability for action plans and issue resolution.
• Lead patient safety and quality escalations, including quality holds and immediate response to risks affecting patient safety, result integrity, or compliance.
• Partner with Clinical Operations, Medical, HR, Legal, IT, Finance, and Operations to embed quality standards across the organization.
• Lead and develop the Quality Assurance team, internal auditors, document controllers, and quality champions through training, performance management, and capability building.

Required profile

• Bachelor’s degree in Medical Technology, Medical Laboratory Science, Healthcare Quality, or a related health science field; active Philippine Medical Technologist license preferred.
• At least 8 years of experience in laboratory, diagnostics, hospital, or healthcare quality, including 3 years in a quality leadership role.
• Strong knowledge of ISO 15189, ISO 9001, DOH requirements, audits, CAPA, document control, and quality management systems.
• Internal/Lead Auditor training preferred; Quality, Risk, Lean, or Six Sigma certifications are an advantage.
• Demonstrated sound judgment, integrity, and confidence in identifying and escalating quality or patient‑safety risks.

Required skills

• ISO 15189
• ISO 9001
• DOH regulatory requirements
• Audits and CAPA management
• Document control and change management
• Root‑cause analysis
• Risk assessment
• Data analysis and quality reporting
• Internal/Lead Auditor training
• Quality, Risk, Lean, Six Sigma methodologies