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hace 2 meses
.As part of the Development Quality Team, you will drive Quality Culture with Development, Regulatory and Safety stakeholders, through learning, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined clinical development stakeholder groups and senior leaders in Development, Regulatory and Safety and for the strategic development and delivery of a GCP risk based robust quality management activities for these stakeholders. The Director will mentor junior team members as well as provide guidance when dealing with high risk complex GCP issues. The Director will lead departmental process improvements and support cross functional process improvements.You will be responsible for:Development and execution of the overarching strategy related to proactive and sustainable quality and compliance for assigned areas.Where applicable, represent DQA on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to proactively identify critical to quality risks and mitigation strategy to drive excellence in study design and execution and to minimize risk to regulatory submission/approvalProactively identify Key Quality and Risk Indicators (KQIs/KRIs) for assigned areas and develops mechanisms of KQI/KRI, detection, oversight and trending with relevant stakeholdersWork with Development Quality peers to ensure escalation of risks and issues identified at a study level to relevant stakeholdersAs required, provide guidance to junior team members for global/systemic clinical quality issue investigationsMentor new and existing employees as per established on-boarding plan and on focus improvement areas.Work with cross functional and other quality partners to proactively identify areas of risk, improvement, or KPI/KQIs, as applicableServe as the quality expert for global/systemic clinical quality issue investigations, which includes:- In collaboration with issue owners lead Quality Event reportability assessments, investigations and Root Cause Analysis- Perform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAs- Acts as quality approver for Quality Issues and CAPAs as assigned- Be accountable for leading inspection readiness as assigned including but not limited to:- Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical compliance- Provide guidance to team members in Inspection Readiness and Preparation Activities (e.G., SME training, Mock inspection etc
