HUTCHMED
MAJOR RESPONSIBILITIES AND DUTIES
Maintain the effectiveness of global clinical/GLP quality management system, including monitor US/EU/Japan clinical regulation updates and communicate the changes to global pre-clinical and clinical quality team.
Contribute to Quality and Risk Management Framework across clinical and non-clinical R&D team.
Lead quality issue investigation and CAPA approval.
Drive continuous improvement in clinical trials quality.
Lead international GCP/GVP inspections and partner audits.
Clinical/GLP quality management system
Regularly monitor US/EU/Japan regulation updates.
Communicate the regulation updates (environment change) to the global Quality team.
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 plan 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 learnt 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.
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Maintain the effectiveness of global clinical/GLP quality management system, including monitor US/EU/Japan clinical regulation updates and communicate the changes to global pre-clinical and clinical quality team.
Contribute to Quality and Risk Management Framework across clinical and non-clinical R&D team.
Lead quality issue investigation and CAPA approval.
Drive continuous improvement in clinical trials quality.
Lead international GCP/GVP inspections and partner audits.
Clinical/GLP quality management system
Regularly monitor US/EU/Japan regulation updates.
Communicate the regulation updates (environment change) to the global Quality team.
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 plan 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 learnt 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.
Sign in to set job alerts for “Associate Director Quality Assurance” roles.
#J-18808-Ljbffr