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, Clinical Quality in Durham, NC, to oversee quality management activities in BioPharmaceuticals R&D. The role emphasizes regulatory compliance, inspection readiness, and fostering a culture of quality within 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 have a track record of success in leading quality and compliance activities within a clinical setting.
  • The position offers a competitive base pay ranging from $137,344.80 to $206,017.20 USD along with equity-based long-term incentives.

Matching Summary

Match Score: 85

AstraZeneca is seeking an Associate Director, Clinical Quality in Durham, NC, to oversee quality management activities in BioPharmaceuticals R&D. The role emphasizes regulatory compliance, inspection readiness, and fostering a culture of quality within 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, holidays, health, dental, and 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 preparation support

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 life science or related discipline
  • 4+ years in-depth proven experience in clinical compliance
  • Knowledge of 21 CFR Part 11 regulations

Work Rights

Not specified

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