Senior Lead

4 days ago

Melbourne, Victoria, Australia beBeeQualityDirector Full time $180,000 - $250,000

About the Role

The Associate Director, Quality Strategies will drive Clinical Quality initiatives in the APAC region. This role involves building R&D Quality's presence and executing Quality Strategies and Plans.

Main Responsibilities:

  • Develop and implement R&D Quality strategies for global R&D activities in the region.
  • Partner with regional Research and Development organizations to support successful execution of R&D activities.
  • Lead complex audits including planning, execution, and reporting.
  • Provide leadership to interdisciplinary audit teams for complex systems/process audits.
  • Contribute to Regulatory Authority inspections and provide input on responses to inspection observations.

Key Requirements:

  • BS/BA, MS or PhD in Biotech, Pharma, or Clinical Research Organization with relevant experience.
  • Strong knowledge of GCP regulations, guidelines, and local legislation.
  • Experience working with CROs, vendors, and relationship management.
  • Excellent auditing, communication, and leadership skills.

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