Director, Clinical Quality Assurance

2 weeks ago


Alameda, California, United States Meet Life Sciences Full time

Director, GCP QA Compliance

Our biotech partner is a well-established, commercially successful clinical stage biotech that is seeking a Director of Clinical Quality Assurance to lead the CQA function and build/manage a team. This role will oversee CQA strategy across policies, SOPs, deviations, change control, CAPAs, and vendor audits. This is a great opportunity for a Clinical QA leader to help progress a robust pipeline of therapeutics across oncology, neurology, endocrinology, and more areas. This position will be 3 days onsite in Redwood City, CA.

Responsibilities:

  • Lead Clinical Quality Assurance as a manager to the CQA team supporting various therapeutic area programs in support of successful clinical studies
  • Lead GCP audit strategy including audits of investigative sites, clinical vendors, internal department, TMF, and study documents
  • Represent QA on clinical teams to provide compliance assessment and advice
  • Manage clinical inspections by regulatory bodies across internal and external stakeholders/vendors
  • Hold quality metric analysis for CQA across deviations, CAPAs and other events
  • Use a risk-based approach to implement clinical program audit plans

Requirements:

  • Bachelor's or Master's in a scientific field with progressive experience in biotech/pharma clinical quality for at least 12 years in industry
  • Strong knowledge of GCP QA regulatory requirements and quality systems
  • Experience developing and managing quality processes
  • Risk management, root cause analysis, and inspection support experience
  • Excellent communication, project management, and organizational skills
  • Demonstrated managerial experience of CQA function in biotech/pharma

Contact:

To have a confidential discussion, please contact Amit at amit.uma@ and apply to this job posting.



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