Contribute to Quality and Risk Management Framework / Program across C&R.
Drive continuous improvement for Clinical Trials Quality.
Manage/support GCP inspections relating to clinical research activities.
Support management in the resolution of quality related issues.
Major Responsibilities Duties
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, contributes to the QA strategy and quality oversight plan.
Supports the identification of audit substrate for scheduling as appropriate.
Audit
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
Serves as member of project team through participation in the applicable meetings, providing GCP compliance advice and guidance, to achieve continuous quality improvement in HMP.
Support Significant Quality Issues management, including perform root cause analyses, review remediation (corrective and preventative actions).
Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation.
Inspection management
Provide inspection readiness and management support as appropriate.
Develops and delivers awareness training internally and externally.
Develops and shares lessons leant after inspection with relevant stakeholders.
QA optimization
Participates in the development/enhancement of 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.
Position Qualifications & Requirements
Minimum bachelor’s degree in clinical medicine or Life/Biological Sciences, advanced degree preferred.
Experience in clinical research (min. 5 years) & quality management/ quality control (min. 3 years).
Experience in risk assessment and mitigation planning.