Director/Sr Director, Clinical Quality Assurance

  • 210000 USD - 275000 USD
  • Menlo Park, United States
  • Permanent
Our client is seeking an experienced Director, GCP Quality Assurance to lead the clinical quality assurance programs for their pipeline. The company is a multi-asset company with multiple clinical trials within the neurodegenerative, autoimmune, and ophthalmic disease space. With recent funding and strong Phase 3 data for its lead program, our client is poised to soon deliver their first commercial product to patients in need.

  • Leverage expertise in Good Clinical Practices to provide strategic and technical leadership to clinical study teams, ensuring quality event management documentation is completed in a detailed and timely manner
  • Lead activities to support regulatory submission, including PAI
  • Leverage QA systems to ensure compliance with FDA and EU requirements and ICH guidelines
  • Perform internal and external audits to ensure compliance with policies, procedures, and GCP requirements
  • Develop and implement SOPs, quality manuals, policies, and other quality related documents
  • Develop clinical quality risk management strategies (assessment, mitigation plans, implementation oversight) to identify, assess, and prevent risk associated with clinical operations
  • BS with 10+ years supporting clinical quality assurance efforts
  • Strong understanding of FDA regulations, ICH guidelines, and other government regulatory requirements governing clinical research
  • Expert in creating and executing audit plans including vendor, clinical investigator site, CSV, nd process audits
  • Mastery of QA principles, concepts, practices, and standards

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