Healthcare Quality & Regulatory Advisor - APAC
Core
Drive compliance and quality programs for Healthcare Transportation & Facilities, ensuring adherence to regional regulations and customer requirements.
Role type
Senior Quality & Regulatory Advisor (Healthcare Logistics)
Builds
Compliance frameworks, SOPs, audit readiness, and quality management systems for pharmaceutical/healthcare logistics.
Domain
Healthcare logistics, pharmaceutical distribution, regulatory affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Assurance, Regulatory Affairs, Root Cause Analysis, CAPA management, Internal Audit, Validation programs, Customer Liaison, SOP development, eQMS management, Compliance monitoring
Preferred skills
Warehouse operations experience, IATA CEIV certification knowledge, Six Sigma, Lean Methodology, Process Mapping, Data analytics, Power BI
Technologies
eQMS, Power BI, Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Determine and implement quality policies and procedures; Write and review SOPs and Work Instructions; Lead CAPA process management; Develop and support the Healthcare Quality Management System; Design and implement internal audit programs; Lead certification audits; Manage operations and customer audit programs; Liaise with customers on quality requirements and resolve issues; Consolidate feedback for quality questionnaires and proposals; Lead validation of transportation lanes and critical equipment.
Seniority
Senior, hands-on IC