Healthcare Quality & Regulatory Advisor
$228,800,000–$301,600,000 year
On-siteNew Taipei City, Taipei, Taiwan
Job Summary
Drive compliance and quality programs for Healthcare Transportation by determining policies, writing SOPs, and managing CAPA processes to ensure adherence to GDP, GCP, and cGMP standards. Lead certification audits, internal audit programs, and validation efforts for cold chain facilities and packaging systems while acting as a Super User for the eQMS system. Liaise with customers to resolve quality issues through root cause analysis and consolidate feedback for regulatory questionnaires and RFQ proposals. Support local Quality teams and provide backup assistance to healthcare specialists across market depots. Based in Taiwan, this role requires five to seven years of experience in pharmaceutical quality and regulatory affairs.
Required Qualifications
- 5 -7 years of relevant experience in Transportation, quality + QMS for pharmaceutical / healthcare industry in quality related role
- good understanding on cold chain transportation compliance
- 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 for warehouse in healthcare industry
- This role is to be based in Taiwan
- 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
- competency in Microsoft Office applications like Excel, Word, and PowerPoint
- Mon to Fri 9am-6pm
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