MAJOR RESPONSIBILITIES AND DUTIES
Clinical/GLP quality management system
- Regularly monitor US/EU/Japan regulation updates.
- Communicate the regulation updates (environment change) to the global Quality teams.
- Ensure global QMS team remediating identified gaps.
Clinical risk assessment and quality oversight plan
- Collaborates with Hutchmed Clinical to perform risk assessments and identify key data/procedures and high-risk areas.
- Proactively analyze quality data and leverage quality indicators to identify potential trends and risks.
- In alignment with risk assessments, develop GCP quality strategy and oversight plan.
Audit
- Set up annual GCP/GLP audit pan based on risk assessment.
- Ensure conducting GCP/GLP audits per approved annual plan.
- Prepares, conducts audits assigned, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations)
- Oversee audits conducted by third party auditing company, including the review of audit plan, audit report, CAPA plan and tracking CAPAs to close out.
- Interacts with various teams to ensure properly performing root-cause analysis and developing corrective and preventative actions (CAPA).
- Track CAPA closure with applicable QA inputs.
GCP quality expert
- Providing GCP compliance advice and guidance to study team.
- Lead Quality Issues investigation, including root cause analyses, remediation (corrective and preventative actions) action review.
- Ensure timely reporting critical quality issues to management team and authorities, e.g. potential misconduct and/or fraud.
Inspection management
- Lead inspection readiness and inspection management for the authority inspections happened ex-China.
- Develops and shares lessons leant with relevant stakeholders after inspection when necessary.
QA optimization
- Enhance QA procedures though updated SOPs, guidance documents and other tools.
- Provides training and mentorship to less experienced QA staff.
- Contributes to build the work climate/culture within QA function, exemplifies the leadership behaviors.
QUALIFICATIONS
- Minimum bachelor’s degree in clinical medicine or Life/Biological Sciences, advanced degree preferred.
- Experience in clinical research (min. 15 years) & quality management/ quality control (min. 10 years), including investigator site audit/vendor audit/CSR audit/TMF audit, etc.
- Experience in clinical risk assessment and mitigation planning.
- Strong English writing and speaking.
- Nice to be able in Chinese writing and speaking
