Quality Lead

• To work with and on behalf of CTPQ/GCP Compliance Management within DevOps, performing management Significant Quality Events.

• Significant Quality Event Lead: the individual responsible for the formation and leading of the Significant Quality Event Team and coordinating all activities related initiating immediate action, conducting Investigation/RCA, developing corrective and preventive actions, as needed, and documenting case activities within appropriate database

• Conduct broader impacts across the portfolio to share learnings with other impacted study teams.

• Interaction with: A diverse range of stakeholders from varying internal lines

• Ability to: be an effective project manager, leadership of Significant Quality Event Teams and/or Investigation/RCA Teams, progress delivery of actions

• Understanding/knowledge of: GCP, clinical trial processes and systems , CAPA, quality issues, regulatory requirements, quality management, Root Cause Analysis, inspection readiness

• Significant Quality Event management

• Forming Significant Quality Event Team

• Arranging meetings with Significant Quality Event Team, RCA Team, and/or Business Process Owner within timelines specified

• Documenting meeting outcomes in meeting minutes or other

• Facilitating Root Cause Analysis (or other types of investigation) and producing outputs

• Ensuring appropriate actions assigned and progressed to completion

• Updating the appropriate database

• Ensuring all documentation is filed appropriately