Director, Clinical Quality Assurance (cqa)

4dmoleculartherapeutics

Remote
Base: $205,000 - $235,000; bonus/equity: not speci...
**
10+ years regulated environment experience
4 years clinical quality assurance experience
Gcp audits and global trial oversight
** 4D Molecular Therapeutics is seeking a Director of Clinical Quality Assurance to oversee quality assurance for global clinical trials, ensuring compliance with Good Clinical Practice (GCP) standards. The ideal candidate will have extensive experience in clinical quality assurance within the biotech industry and will be responsible for developing quality plans, conducting audits, and fostering a quality-focused work environment. **

Job Summary

  • The Director will provide Quality Assurance oversight for multiple global clinical trials ensuring compliance with Good Clinical Practice (GCP).
  • Responsibilities include developing study-specific quality plans, performing GCP compliance audits, and managing corrective and preventive actions (CAPAs).
  • The role requires extensive practical experience in clinical quality assurance throughout the clinical development life-cycle within a fast-paced environment.

Matching Summary

Match Score: 75

** 4D Molecular Therapeutics is seeking a Director of Clinical Quality Assurance to oversee quality assurance for global clinical trials, ensuring compliance with Good Clinical Practice (GCP) standards. The ideal candidate will have extensive experience in clinical quality assurance within the biotech industry and will be responsible for developing quality plans, conducting audits, and fostering a quality-focused work environment. **

Salary

Base: $205,000 - $235,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 10+ years regulated environment experience
  • 4 years clinical quality assurance experience
  • GCP audits and global trial oversight
  • ICH E6 Risk Management principles
  • CAPA investigation and resolution

Nice-to-have

  • Management experience in QA
  • APAC region trial experience
  • Fast-paced small company adaptability
  • Collaborative team approach
  • Advanced scientific degree preferred

Key Requirements

  • S./B.A. degree in science or related field
  • 10+ years experience in regulated environment
  • Minimum 4 years significant clinical QA experience
  • Experience with GCP Quality Management Systems
  • In-depth understanding of GCP requirements

Work Rights

Not specified

Tailored Resume

Cover Letter