Director, Clinical Quality Lead

Kardigan

California, United States
Base: $194,000 - $253,000 usd; bonus/equity: not s...
On-site
15+ years pharmaceutical industry experience
7+ years qms environment experience
Direct experience with clinical systems audits
Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable through targeted treatments

Job Summary

  • Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable through targeted treatments.
  • The Clinical Quality Lead will drive a culture of quality by managing GxP QA functions and ensuring compliance throughout the R&D process.
  • This role requires maintaining current regulatory inspection knowledge and leading backroom activities during regulatory authority inspections.

Matching Summary

Kardigan is a heart health company dedicated to making cardiovascular disease preventable and curable through targeted treatments.

Salary

Base: $194,000 - $253,000 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • 15+ years pharmaceutical industry experience
  • 7+ years QMS environment experience
  • Direct experience with clinical systems audits
  • Expertise in Root Cause Analysis and CAPA
  • Knowledge of GCP, GLP, and GVP regulations

Nice-to-have

  • Strong interpersonal and negotiation skills
  • Experience working in culturally diverse global teams
  • Proven excellence in communication and organization
  • Ability to work independently and prioritize tasks

Key Requirements

  • Bachelor's degree in a scientific discipline
  • 15+ years in pharmaceutical or biotechnology industry
  • 7+ years in a QMS environment
  • Available to be on site 4 days/week
  • Available to travel as needed

Work Rights

Not specified

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