Healthcare Quality & Regulatory Advisor

Position Summary

This position plays a critical role in driving compliance and quality programs for Healthcare Transportation and supporting the Healthcare Quality Management System to ensure processes and systems are compliant with regional and local regulations and customer requirements.

Key Responsibilities

• 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
• Write & review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry
• Implement compliance and quality programs to support local Quality teams to ensure they are kept up-to-date and prepared
• 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
• Develop, implement & support the Healthcare Quality Management System and processes, develop corresponding training programs, and acts as Super User for eQMS system
• Design & implement robust internal audit processes to ensure readiness of various functions & processes when meeting regulatory agencies & customer audits
• Lead various certification audits with relevant regulatory agencies and certification providers across the region
• Lead & prepare for regular audit programs / random checks / regulatory activities to achieve successful audit outcomes and proper post audit follow up actions
• 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 root cause analysis
• Liaise, consolidate feedback from different functions to update and prepare final copy for Quality Questionnaires, Agreements and RFQ Proposals for customers
• Lead the validation of transportation lanes and critical equipment like cold chain facilities, and packaging systems
• Provide secondary / backup support to healthcare specialists for market depots

Requirements

• Have at least 5-7 years of relevant experience in Transportation, quality + QMS for pharmaceutical / healthcare industry in quality related role
• Experience working in airport and have good understanding on cold chain transportation compliance
• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
• Have working experience ensuring compliance in accordance to Good Manufacturing Practice (cGMP), Good Clinical Practices (cGCP), Good Distribution Practice (GDP) & ISO13485 for Medical Devices
• Experience in conducting external and internal audits for Japan warehouse in healthcare industry
• This role is to be based in Thailand

Required Skills

• Accuracy & attention to detail which is crucial to proper compliance to regulatory and standards
• Problem-solving skills to support customer issue resolution
• Planning & organization skills to ensure proper audit programs are managed effectively
• Communication skills to facilitate engagements with customer and regulatory agencies
• Project management capabilities and familiarity with Process Mapping, Six Sigma, Lean Methodology, Agile or Design Thinking
• Apply data-driven decision making with the use of data analytics and visualization tools like Power BI and competency in Microsoft Office applications like Excel, Word, and PowerPoint

Working Hours

Mon to Fri 9am-6pm