Associate Director, Development Asset Quality, Daq
hace 4 meses
**Associate Director, Development Asset Quality (DAQ)Location**: Barcelona This is what you will do: 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 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. Director will be responsible for managing the Associate Directors/study quality leads including but not limited to providing mentoring, coaching, development etc.You will be responsible for: Assisting in the development of an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs)Where applicable, represent DAQ 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 execution and to minimize risk to regulatory submission/approval.Work with cross functional and other quality partners to proactively identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develops mechanisms of KQI/KRI, detection, oversight and trending with Clin development and Ops stakeholders and other stakeholders and functions such as Risk based Quality ManagementServe 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 AnalysisPerform Quality Event risk assessments and trending (deviations, audit findings, inspection findings etc.) to determine robust CAPAsActs as quality approver for Quality Issues and CAPAs as assigned Be accountable for leading inspection readiness for assigned programs/portfolio including but not limited to: Provide leadership and guidance to team members in promoting a culture of inspection readiness and sustainable clinical complianceProvide guidance to team members in Inspection Readiness and Preparation Activities (e.g., SME training, Mock inspection etc.)Support follow up and tracking of inspection commitment and effectiveness check for assigned programs/Therapeutic AreaServe as the Subject Matter Expert (SME) and provide guidance on major processes/platforms optimization and quality governance requirements where applicable e.g., TMF health oversight, CRO/Vendor oversight, medical device requirements etc. Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities to minimize recurrence of similar issuesActively participate in meetings driving quality and business performanceSupport Due Diligence and integration activities as assigned You will need to have: Bachelors degree in life science, or equivalent field, required Minimum of 8+ years of experience in clinical research area inclusive of, but not limited to, Good Clinical Practice or Good Clinical Practice quality assurance and complianceEstablished knowledge of GxP/GCP regulations and guidelines (EMA, FDA, PMDA etc.) Significant experience with GxP investigations, risk assessments and CAPA managementExperience participating in regulatory inspectionsFunctional planning experience and ability to develop functional vision, priorities and tacticsExperience with multinational products and regulations as well as with mandated risk management plansAbility to travel up to 10%The duties of this role are generally conducted in an office environment.
As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have: Advanced degree preferredCompetencies to be successful for this position include: Quality, process, and compliance orientedStrong interpersonal skills Critical thinkingIntegrityCommunicationTeamworkProblem solving
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