Associate Director, Gcp Quality Assurance

Olema

San Francisco, CA, United States
Base: $190,000 - $210,000 annually; bonus/equity: ...
On-site
Gcp/gvp compliance
Internal and external audits
Regulatory authority inspections
Partner with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance

Job Summary

  • Partner with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance.
  • Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP.
  • Manage Quality Management System (QMS) including QA review/approval of deviations, CAPAs and change controls.

Matching Summary

Partner with Clinical Development/Operations, Pharmacovigilance and Safety in cross-functional study teams to drive GCP/GVP compliance.

Salary

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

Skills & Requirements

Must-have

  • GCP/GVP compliance
  • internal and external audits
  • regulatory authority inspections
  • Quality Management System (QMS)
  • risk-based GCP compliance

Nice-to-have

  • positive, collaborative relationships
  • fast-paced, matrixed, team environment
  • analytical thinker with problem-solving skills

Key Requirements

  • Bachelor’s Degree or higher in a scientific discipline
  • Minimum of 8 years of relevant experience
  • Demonstrated experience leading and/or conducting QA audits
  • Hands-on experience with regulatory inspections
  • Experience writing and reviewing SOPs

Work Rights

Not specified

Tailored Resume

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