Associate Director, Clinical Quality

AstraZeneca

Durham, NC, US
Base: $137,344.80 - $206,017.20 usd; bonus/equity:...
3 days in-office
4+ years clinical compliance experience
Gcp guidelines and ich guidance knowledge
Root cause analysis and capa management
AstraZeneca is seeking an Associate Director of Clinical Quality in Durham, NC, responsible for enhancing quality management practices in clinical operations through compliance initiatives and inspection readiness activities. The ideal candidate will have significant experience in clinical compliance and project management, with a strong understanding of GCP guidelines

Job Summary

  • The role is responsible for supporting quality partnering across BioPharmaceuticals R&D to provide data-driven insights for inspection readiness.
  • Candidates must establish effective systems to maintain Quality Management excellence while promoting a culture of quality across the organization.
  • The position offers a competitive base pay range, short-term incentive bonuses, equity-based long-term incentives, and comprehensive health benefits.

Matching Summary

Match Score: 85

AstraZeneca is seeking an Associate Director of Clinical Quality in Durham, NC, responsible for enhancing quality management practices in clinical operations through compliance initiatives and inspection readiness activities. The ideal candidate will have significant experience in clinical compliance and project management, with a strong understanding of GCP guidelines.

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, leaves, medical, dental, vision coverage

Skills & Requirements

Must-have

  • 4+ years clinical compliance experience
  • GCP guidelines and ICH guidance knowledge
  • Root cause analysis and CAPA management
  • Regulatory inspection readiness support
  • Risk identification and mitigation

Nice-to-have

  • Proven project management skills
  • Higher degree in scientific discipline
  • Benchmarking with industry peers
  • Culture of quality championing
  • Continuous improvement opportunities

Key Requirements

  • Bachelor's degree in life science or related field
  • 4+ years in-depth clinical compliance experience
  • Knowledge of GCP, ICH, and 21 CFR Part 11

Work Rights

Not specified

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