PRIMARY FUNCTION
61 Contribute to Quality and Risk Management Framework across C&R.
61 Set up GCP audit plan according to the risk assessment and track the progress.
61 Coach GCP auditor in audit process and improve their capabilities.
61 Drive continuous improvement for Clinical Trials Quality.
61 Lead GCP inspections relating to clinical research activities.
61 Support quality issue investigation and CAPA approval.

MAJOR RESPONSIBILITIES, AND DUTIES
Risk assessment and quality oversight plan
61 Collaborates with the line functions within C&R, to perform risk assessments and identify key data/procedures and high risk areas.
61 Proactively analyses quality data and leverages quality indicators to identify potential trends and risks.
61 In alignment with risk assessments, develop GCP quality strategy and quality oversight plan.
Audit
61 Set up annual GCP audit pan, and obtain approval from Head of Clinical Quality Assurance.
61 Ensure GCP audits to be conducted per the annual plan.
61 Prepares, conducts QA audits, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations)
61 Interacts with various teams to ensure proper root cause analysis is performed and corrective and preventative actions are developed and approved.
61 Tracks corrective and preventative actions and bring QA observations to closure as applicable.
GCP quality expert
61 Providing GCP compliance advice and guidance to GCP auditor and study team.
61 Lead critical Quality Issues investigation, including perform root cause analyses, review remediation (corrective and preventative actions).
61 Ensures appropriate and timely reporting of quality issues to management team and authorities, including potential misconduct or issues of significant deviation.
Inspection management
Risk assessment and quality oversight plan
· Collaborates with the line functions within C&R, to perform risk assessments and identify key data/procedures and high risk areas.
· Proactively analyses quality data and leverages quality indicators to identify potential trends and risks.
· In alignment with risk assessments, develop GCP quality strategy and quality oversight plan.
Audit
· Set up annual GCP audit pan, and obtain approval from Head of Clinical Quality Assurance.
· Ensure GCP audits to be conducted per the annual plan.
· Prepares, conducts QA audits, generates audit reports on time, communicates results to relevant stakeholders (e.g. Vendors/Clinical Operations)
· Interacts with various teams to ensure proper root cause analysis is performed and corrective and preventative actions are developed and approved.
· Tracks corrective and preventative actions and bring QA observations to closure as applicable.
GCP quality expert
· Providing GCP compliance advice and guidance to GCP auditor and study team.
· Lead critical Quality Issues investigation, including perform root cause analyses, review remediation (corrective and preventative actions).
· Ensures appropriate and timely reporting of quality issues to management team and authorities, including potential misconduct or issues of significant deviation.
Inspection management
· Lead inspection readiness and management.
· Develops and delivers awareness training internally and externally.
· Develops and shares lessons leant after inspection with relevant stakeholders.
QA optimization
· Develop/enhance QA procedures, guidance documents and audit tools to ensure continues improvement.
· Promotes standardization of auditing approach within QA.
· Routinely suggests new audit techniques/aids in areas of technical expertise
· Provides training and mentorship to less experienced members of 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. 10 years) & quality management/ quality control (min. 7 years).
Experience in risk assessment and mitigation planning.
Good at English writing and speaking.