Healthcare Quality & Regulatory Advisor
$7,280,000–$9,360,000 year
On-siteGuangzhou, Guangdong, China
Job Summary
Drive compliance and quality programs for Healthcare Transportation & Facilities by determining, implementing, and promoting policies to ensure adherence to GDP, GCP, and other standards. Write, review SOPs, and lead the validation of transportation lanes, cold chain facilities, and packaging systems while managing CAPA processes from creation to closure. Develop and support the eQMS system as a Super User, design internal audit programs, and lead certification audits with regulatory agencies and customers. Liaise with customers to resolve quality issues via root cause analysis and consolidate feedback for RFQ proposals. Provide secondary support to healthcare specialists at market depots. Based in Guangzhou, China, with a Monday to Friday 9am-6pm schedule.
Required Qualifications
- at least 5 -7 years of relevant experience in warehouse, quality + QMS for pharmaceutical / healthcare industry in quality related role
- competencies in quality assurance / regulatory affairs, customer relationship management and root cause analysis
- working experience ensuring compliance in accordance to Goods Manufacturing Practise cGMP, Good Clinical Practises cGCP, Goods Distribution Practice (GDP) & ISO13485 for Medical Devices
- Experience in conducting external and internal audits
- This role is to be based in Guangzhou, China
- Mon to Fri 9am-6pm
Desired Qualifications
- Experience working in warehouse is desire
- IATA CEIV certification knowledge would be at advantage
- 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
- competency in Microsoft Office applications like Excel, Word, and PowerPoint
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