Associate Director, Gcp Qa

Mirum Pharmaceuticals

Foster City, US
$190,000 to $205,000 usd; not specified; not speci...
On-site
Gcp/gvp/glp qa support
Clinical study programs
Vendor oversight
Mirum Pharmaceuticals seeks an Associate Director of GCP QA to oversee quality assurance in clinical studies, ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in GCP quality assurance, particularly with global contract research organizations, and a strong background in pharmaceutical regulations

Job Summary

  • Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases.
  • The Associate Director of GCP/GVP/GLP-QA is responsible for supporting Mirum’s clinical study programs as the GCP-QA representative on the study management team.
  • This position requires experience with global contract research organizations (CROs) and GCP Vendors as well as knowledge of global GCP regulations.

Matching Summary

Match Score: 85

Mirum Pharmaceuticals seeks an Associate Director of GCP QA to oversee quality assurance in clinical studies, ensuring compliance with regulatory standards. The ideal candidate will have extensive experience in GCP quality assurance, particularly with global contract research organizations, and a strong background in pharmaceutical regulations.

Salary

$190,000 to $205,000 USD; Not specified; Not specified

Skills & Requirements

Must-have

  • GCP/GVP/GLP QA support
  • Clinical study programs
  • Vendor oversight
  • Regulatory compliance
  • Audit program management

Nice-to-have

  • Collaborative and creative
  • Passionate about rare diseases
  • Embody company values
  • Fun, seriously

Key Requirements

  • Bachelor's Degree in a scientific discipline
  • 10-12 years of pharmaceutical industry experience
  • 5-10 years in GCP Quality
  • 5+ years supervising GCP Quality staff/consultants
  • Knowledge of GCP, FDA, EMA, and ICH guidelines
  • Experience with global CROs and GCP Vendors

Work Rights

Not specified

Tailored Resume

Cover Letter