Director Strategic Advice - R&d Quality Assurance

AstraZeneca

Gaithersburg, MD, USA
Base: $150,227.20 - $225,340.80 usd; bonus/equity:...
Hybrid
10+ years pharmaceutical industry experience
Gvp and gcp regulatory expertise
End-to-end regulatory inspection strategy
This role involves influencing strategic directions on quality and compliance as a GVP/GCP expert for clinical and post-market activities

Job Summary

  • This role involves influencing strategic directions on quality and compliance as a GVP/GCP expert for clinical and post-market activities.
  • The position requires delivering end-to-end regulatory inspection strategy and managing business relationships with senior R&D leaders.
  • AstraZeneca offers a Great Place to Work environment with benefits including medical insurance, annual bonuses, and education cost reimbursement.

Matching Summary

This role involves influencing strategic directions on quality and compliance as a GVP/GCP expert for clinical and post-market activities.

Salary

Base: $150,227.20 - $225,340.80 USD; Bonus/Equity: Eligible for short-term incentives and equity-based awards; Benefits: Qualified retirement programs, paid time off, health/dental/vision coverage

Skills & Requirements

Must-have

  • 10+ years pharmaceutical industry experience
  • GVP and GCP regulatory expertise
  • End-to-end regulatory inspection strategy
  • Critical quality issue investigation leadership
  • Stakeholder influence and strategic direction

Nice-to-have

  • Six Sigma or Lean process improvement tools
  • Project management and key account management
  • AI curiosity and technology management skills
  • Solutions-focused attitude for complex challenges
  • Inclusive culture championing diversity

Key Requirements

  • Bachelor's degree required, Master's preferred
  • 10+ years in pharmaceuticals or life sciences
  • Thorough understanding of GxP (GVP/GCP) standards
  • Experience managing regulatory health authority inspections

Work Rights

Not specified

Tailored Resume

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