Gr-369 | Associate Director, Development Asset Quality, Daq

hace 3 semanas

Barcelona, España Importante Empresa A tiempo completo

.Associate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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 GCP risk-based robust quality management activities for these stakeholders. You will also manage Associate Directors/study quality leads, including but not limited to providing mentoring and coaching.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 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 develop mechanisms of KQI/KRI detection, oversight, and trending with Clinical Development and Ops stakeholders.Serve as the quality expert for global/systemic clinical quality issue investigations, including leading 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.Act as quality approver for Quality Issues and CAPAs as assigned.Lead inspection readiness for assigned programs/portfolio, providing 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.).Support follow-up and tracking of inspection commitments and effectiveness checks for assigned programs/Therapeutic Area.Serve 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 issues.Actively participate in meetings driving quality and business performance.Support Due Diligence and integration activities as assigned.You will need to have:Bachelor's degree in life science or equivalent field, required

  • Gr-369 | Associate Director, Development Asset Quality, Daq

    hace 2 semanas

    Barcelona, España Importante Empresa A tiempo completo

    Associate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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...

  • Gr-369 | Associate Director, Development Asset Quality, Daq

    hace 3 semanas

    Barcelona, España Importante Empresa A tiempo completo

    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...

  • Gr-369 | Associate Director, Development Asset Quality, Daq

    hace 3 semanas

    Barcelona, España Importante Empresa A tiempo completo

    Associate Director, Development Asset Quality (DAQ)Location: BarcelonaThis 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...

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    Barcelona, España AstraZeneca A tiempo completo

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    hace 7 días

    Barcelona, Barcelona, España Importante Empresa A tiempo completo

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