About the role

  • Provide quality oversight and GCP guidance to clinical study teams and vendors
  • Ensure compliance with ICH GCP and FDA regulatory requirements
  • Evaluate clinical trial documentation and processes
  • Conduct regular vendor audits or assessments

Requirements

  • BA/BS in life sciences or related field
  • Minimum of 4 years of experience in a GCP QA/quality/compliance role
  • Working knowledge of GCP regulations and guidelines, including ICH, FDA, EMA, and PMDA requirements
  • Experience in performing GCP-related audits

Benefits

  • Health insurance
  • 401(k) matching
  • Paid time off
  • Flexible work hours

Job title

Senior Manager, GCP QA

Job type

Experience level

Senior

Salary

$135,000 - $165,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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