Associate Director, Gcp Quality Assurance

Olema

San Francisco, CA, United States
Base: $190,000 - $210,000 annually; bonus/equity: ...
On-site
Gcp/gvp compliance
Clinical trial risk assessment
Audit preparation and execution
Partner with Clinical Development/Operations and Pharmacovigilance to drive GCP/GVP compliance, identifying clinical trial-related risks and opportunities for process improvement

Job Summary

  • Partner with Clinical Development/Operations and Pharmacovigilance to drive GCP/GVP compliance, identifying clinical trial-related risks and opportunities for process improvement.
  • Perform internal and external audits, manage CAPAs, and support regulatory authority inspections to ensure compliance with GCP/GVP regulations and guidelines.
  • Oversee quality aspects of clinical study start-up, execution, and close-out, and manage the Quality Management System including deviations, CAPAs, and change controls.

Matching Summary

Partner with Clinical Development/Operations and Pharmacovigilance to drive GCP/GVP compliance, identifying clinical trial-related risks and opportunities for process improvement.

Salary

Base: $190,000 - $210,000 annually; Bonus/Equity: equity, bonus; Benefits: benefits

Skills & Requirements

Must-have

  • GCP/GVP compliance
  • clinical trial risk assessment
  • audit preparation and execution
  • regulatory authority inspections
  • Quality Management System (QMS)

Nice-to-have

  • driving positive company culture
  • developing meaningful therapies
  • working in a fast-paced environment

Key Requirements

  • Bachelor's Degree or higher in a scientific discipline
  • Minimum of 8 years of relevant experience
  • Experience with regulatory inspections
  • Experience writing and reviewing SOPs
  • Experience using QMS (Veeva systems preferred)

Work Rights

Not specified

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