Associate Director, Clinical Quality

Astrazeneca

Durham, NC, US
Base: $137,344.80 - $206,017.20 usd; bonus/equity:...
3 days onsite
4+ years clinical compliance experience
Knowledge of gcp guidelines and ich guidance
Proven project management skills
AstraZeneca is seeking an Associate Director of Clinical Quality in Durham, NC, responsible for ensuring quality management within BioPharmaceuticals R&D. The role focuses on inspection readiness, regulatory compliance, and promoting a culture of quality across clinical operations

Job Summary

  • The role is responsible for supporting quality partnering across BioPharmaceuticals R&D to provide data-driven insights for inspection readiness.
  • Candidates must facilitate the delivery of Quality Management activities while leading proactive inspection readiness activities within Clinical Operations.
  • The position offers a competitive annual base pay ranging from $137,344.80 to $206,017.20 USD along with short-term incentive bonuses and equity programs.

Matching Summary

Match Score: 85

AstraZeneca is seeking an Associate Director of Clinical Quality in Durham, NC, responsible for ensuring quality management within BioPharmaceuticals R&D. The role focuses on inspection readiness, regulatory compliance, and promoting a culture of quality across clinical operations.

Salary

Base: $137,344.80 - $206,017.20 USD; Bonus/Equity: Short-term incentive bonus and equity-based long-term incentive program available; Benefits: 401(k), paid vacation, health/dental/vision coverage

Skills & Requirements

Must-have

  • 4+ years clinical compliance experience
  • Knowledge of GCP guidelines and ICH guidance
  • Proven project management skills
  • Experience with CAPA and root cause analysis
  • Inspection readiness and regulatory adherence

Nice-to-have

  • Higher degree in scientific or business discipline
  • Benchmarking with industry peers
  • Culture of quality champion mindset
  • Continuous improvement opportunities identification

Key Requirements

  • Bachelor's degree in related discipline (life science preferred)
  • 4+ years in-depth proven experience in clinical compliance
  • Knowledge of 21 CFR Part 11 and GCP standards

Work Rights

Not specified

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