Director, Central Quality Audit, Pharmacovigilance

GE HealthCare UK

Base: $142,400.00-$213,600.00 annual; bonus/equity...
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Global pharmacovigilance audit strategy ownership
Lead auditor certification with active status
5+ years people leadership experience
** GE HealthCare UK is seeking a Director for Central Quality Audit in Pharmacovigilance. The role involves managing the global pharmacovigilance audit program, ensuring compliance with regulations, and leading a team of auditors while fostering a culture of integrity and collaboration. **

Job Summary

  • The role involves owning the global Pharmacovigilance audit strategy to ensure alignment with regulatory expectations from agencies like the EMA, FDA, and MHRA.
  • Candidates will lead a team of 3–5 auditors while managing internal audits, service provider assessments, and health authority inspections.
  • GE HealthCare offers a competitive benefits package including medical, dental, vision, paid time off, and a 401(k) plan with company contributions.

Matching Summary

Match Score: 75

** GE HealthCare UK is seeking a Director for Central Quality Audit in Pharmacovigilance. The role involves managing the global pharmacovigilance audit program, ensuring compliance with regulations, and leading a team of auditors while fostering a culture of integrity and collaboration. **

Salary

Base: $142,400.00-$213,600.00 Annual; Bonus/Equity: Performance based incentive compensation available; Benefits: Medical, dental, vision, 401(k), PTO, tuition reimbursement

Skills & Requirements

Must-have

  • Global Pharmacovigilance audit strategy ownership
  • Lead Auditor certification with active status
  • 5+ years people leadership experience
  • Experience with FDA CFR 21 820 and ISO 13485
  • Knowledge of cGMP, GDP, GPvP, GCP, and GLP

Nice-to-have

  • Prior Veeva and TrackWise Digital experience
  • Six Sigma or Lean Six Sigma methodology
  • IRCA, ASQ CQE, or CQA certifications
  • Health authority inspection support experience
  • Strong conflict-resolution and communication skills

Key Requirements

  • Master's degree plus 5+ years in PV or Bachelor's plus 10+ years
  • Minimum 5 years driving global quality compliance programs
  • Active Lead Auditor certification required
  • Must be legally authorized to work in the US (no sponsorship)

Work Rights

Must be legally authorized to work in the United States

Tailored Resume

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