Under the direction of the Clinical QA Lead, the position is responsible for leading the QA activities of assigned programs being managed by the Clinical Development organization. Primary responsibilities for this role provide batch record review, review deviations, CAPA, assist with QTA's and release of Clinical Supplies.
- Execution of Batch Record Review, Liaise with Contract Manufacturers, review deviations, attend project meetings and release of Clinical supplies.
- Collaboratively works with key stakeholders from project teams and other Clinical QA colleagues to ensure QA tasks are completed as per plan execution.
- Ensures the appropriate corrective and preventive actions are completed in a timely manner as a result of deviations.
- As appropriate, escalates issues of critical noncompliance and/or lack of urgency in remediation to management.
- Works with the PDTS team to perform program specific root cause analysis of deviations and provide the appropriate metrics for tracking, trending for the overall reporting requirements to functional management.
Education and Experience Requirements:
- Bachelor's degree in a life science preferred; Master's Degree in a scientific discipline a plus.
- At least 4 - 6 years of pharmaceutical experience required.
- Ideal candidate will have broad experience in product development, clinical operations, clinical QA and regulatory compliance.
Sthree US is acting as an Employment Business in relation to this vacancy.