Work closely with regional and global quality leaders, local study teams, and key stakeholders to make sure every stage of the clinical trial process from protocol design to regulatory submission runs smoothly and meets both global and local expectations.
Partner with clinical study teams to review and refine trial protocols, ensuring simplicity and focus on critical data and processes.
Use advanced risk-assessment tools to evaluate study risks and implement effective mitigation strategies to safeguard patient safety, data accuracy, and regulatory compliance.
Lead the development of Taiwan-specific quality plans and ensure alignment with regional and local regulatory requirements.
Collaborate with Regional Clinical Quality Leads on topics like biomarkers, imaging, and data integrity across clinical programs.
Contribute to quality assurance plans and audits at study, site, and affiliate levels.
Support cross-functional teams on quality issue management, CAPAs, deviations, and inspection readiness.
Monitor compliance trends, analyze key metrics, and share insights with leadership to drive continuous improvement.
Explore new technologies and data-driven methods (AI, NLP, analytics) to strengthen quality oversight and efficiency.
Requirement:
Bachelor's degree (or equivalent) in Life Sciences, Biomedical Science, Nursing, or a related field.
At least 5 years of experience in the pharmaceutical or biotech industry and strong understanding of ICH-GCP, clinical R&D operations, and both global and local regulatory frameworks.
Experience with Quality Management Systems, ideally using electronic systems such as Veeva or TrackWise.
Excellent communication and business writing skills both in English and Mandarin able to simplify complex information and build trust across teams.
Strong analytical, critical-thinking, and decision-making skills. A collaborative mindset with the ability to work across functions and cultures.
