Associate Director, Clinical Quality Assurance

Veratherapeuticsinc

Remote
$140,000—$214,000 usd py
**
Gcp and regulatory expectations
Quality events, investigations, and capas
Risk-based decision making
** Vera Therapeutics is seeking an Associate Director of Clinical Quality Assurance to provide quality oversight for clinical development activities within their biotechnology company focused on immunological diseases. The role involves ensuring compliance with regulatory standards and enhancing the organization’s Quality Management System. **

Job Summary

  • The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities.
  • This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs.
  • The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle.

Matching Summary

Match Score: 75

** Vera Therapeutics is seeking an Associate Director of Clinical Quality Assurance to provide quality oversight for clinical development activities within their biotechnology company focused on immunological diseases. The role involves ensuring compliance with regulatory standards and enhancing the organization’s Quality Management System. **

Salary

$140,000—$214,000 USD

Skills & Requirements

Must-have

  • GCP and regulatory expectations
  • Quality events, investigations, and CAPAs
  • Risk-based decision making
  • CROs and vendor quality representatives
  • Inspection readiness activities

Nice-to-have

  • Strengthening maturing QMS
  • Risk-based quality management
  • Procedural governance
  • Quality process improvement

Key Requirements

  • 8+ years of industry experience
  • Leadership in clinical quality oversight
  • Applied knowledge of global GxP regulations
  • Bachelor's degree in life sciences
  • Advanced degree preferred

Work Rights

Not specified

Tailored Resume

Cover Letter