Associate Director, Development Asset Quality

hace 6 días

Barcelona, Barcelona, España Importante Empresa A tiempo completo
Job Title: Associate Director, Development Asset Quality

At Importante Empresa, we are seeking an experienced Associate Director, Development Asset Quality to join our team. As a key member of our 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.

Key Responsibilities:
  • Manage business relationships with defined stakeholder groups and senior leaders in Development, Regulatory, and Safety.
  • Develop and deliver GCP risk-based robust quality management activities for these stakeholders.
  • Manage Associate Directors/study quality leads, including mentoring and coaching.
  • Assist in developing an overarching strategy related to proactive and sustainable quality and compliance for all programs/portfolio for assigned Therapeutic Area(s) (TAs).
  • Represent DAQ on Alexion Global Program Teams (GPTs) and Regulatory Strategy Teams (RSTs) to identify critical to quality risks and mitigation strategy.
  • Work with cross-functional and other quality partners to identify study level Key Quality and Risk Indicators (KQIs/KRIs) and develop mechanisms of KQI/KRI detection, oversight, and trending.
  • Perform Quality Event risk assessments and trending 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.
  • Support follow-up and tracking of inspection commitments and effectiveness checks for assigned programs/Therapeutic Area.
  • Drive continuous improvement and knowledge management by sharing case studies/lessons learned from QA activities.
Requirements:
  • Bachelor's degree in life science or equivalent field, required.

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