Healthcare Quality & Regulatory Compliance Advisor

My Client is a global provider of transportation, e-commerce and business services. In this role, you will lead in managing the Healthcare Quality Management System and implementing compliance programs for Transportation and Healthcare facilities to ensure processes, procedures, and systems are compliant with regional and local regulations and customer requirements.

What you'll do:

• Quality Assessment & Standards: Review SOPs and Work Instructions for transportation & fulfilment solutions pertaining to the healthcare industry.
• Quality Policies: Design, implement & promote policies and procedures for the company's Network and facilities (hubs & stations) to ensure compliance with standards such as GDP, GCP and others.
• Healthcare Quality Management System: Develop, implement & manage the system and develop related training programs.
• Quality Management: Review documentation on the implementation and responses to corrective and preventive actions (CAPAs) and monitor action progress.
• Quality Audit Processes: Design & implement robust internal audit processes to ensure the readiness of various functions and processes when audited by regulatory agencies and customer auditors.
• Certification & Customer Audits: Lead various certification audits with relevant regulatory agencies and certification providers across the region.
• Operations Audit Programs: Lead and conduct External and Vendor audit programs / random checks to achieve successful audit outcomes and proper post-audit follow-up actions.
• Healthcare Customer Liaison: Liaise with customers to understand quality requirements/issues/ underlying concerns to advise on the way forward and support in issue resolution.

What we look for in you!

• Local pharmacist license and may be required to hold licenses on behalf of the company
• Three to five years of relevant experience in the pharmaceutical or healthcare industry in a quality-related role
• Have competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
• Working knowledge of current Goods Distribution Practice (cGDP)/Goods Manufacturing Practise cGMP, Good Clinical Practises cGCP, Goods Distribution Practice (GDP & GxP Framework) & ISO13485 for Medical Devices
• Bachelor's Degree in Science, Pharmacy or related discipline

Your Qualities

• Accuracy & attention to detail which is crucial to proper compliance with 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 and Design Thinking
• Apply data-driven decision-making with the use of data analytics and visualization tools like Power BI