Responsibilities:

• Support and coordinate internal and external audits
• Supporting the development of an annual audit program and schedule
• Lead/Support audit for site, and sponsor clinical audits
• Assess/audit compliance of Clinical Studies to applicable standards and regulations
• Write and distribute Audit schedules, plans, reports. Assess objective evidence to determine conformity to requirements in audit purpose, including ranking the levels of nonconformance findings. Track audit findings and corrective actions. Document completion of corrective actions.
• Develop and maintain clinical/quality metrics
• Participate in NMPA inspections
• Manage and conduct the life cycle of vendor/supplier qualification, conducting (pre-qualification, re-qualification) assessments, risk assessments, scheduling, maintaining an approved vendor list, and complete qualification reports
• Develop Clinical processes that are compliant with applicable standards and regulations
• Maintain and update processes, procedures, and SOPs based on continuous improvement, regulation updates, and user feedback
• Support training Clinical Affairs staff on new/updated regulations, standards, requirements, processes, best practices, SOPs
• Support clinical study teams and help to troubleshoot clinical compliance issues

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.