||Sr. Manager / Manager, GCP auditor
Summary of Relevant Job Responsibilities
- 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.
- 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.
- Good at English writing and speaking.
If interested, please forward your resume to KellyL@hutch-med.com