Healthcare Quality & Regulatory Advisor

Position Summary This position play a critical role in driving compliance and quality programs for Healthcare Transportation & Facilities and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements. Job Scope 1. Quality Policies & Procedures: Determine, implement & promote policies and procedures for company’s Network and facilities (hubs & stations) to ensure compliance to standards such as GDP, GCP and others. 2. Quality Assessment & Standards: Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry. 3. Compliance & Quality Program Management: Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared. 4. CAPA Process Management: Lead in process creation and review of documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress until closure. 5. Healthcare Quality Management System: Develop, implement & support the system and processes, develop corresponding training programs, and acts as Super User for eQMS system. 6. Internal Audit Programs: Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits. 7. Certification Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region. 8. Operations & Customer Audit Programs: Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions. 9. Healthcare Customer Liaison: Liaise with customers to understand quality requirements / issues / underlying concerns to advise on the way forward, provide advice based on interpretations as applicable to 3PL and resolve issues via conducting r…