Director, R&d Diagnostics Quality

Gilead Sciences

California, United States
Base: $210,375.00 - $272,250.00; bonus/equity: dis...
On-site
Strategic quality leadership
Regulatory oversight for diagnostics
Risk-based approach
Gilead Sciences is seeking a Director of R&D Diagnostics Quality to lead strategic quality initiatives and regulatory oversight for diagnostic programs within their global R&D portfolio. The ideal candidate will possess extensive experience in quality systems within the pharmaceutical or biotech industries, particularly in diagnostic roles, and will play a crucial role in ensuring compliance with medical device regulations

Job Summary

  • Provide strategic quality leadership and regulatory oversight for diagnostic and companion diagnostic (CDx) programs across Gilead's global R&D portfolio.
  • Partner cross-functionally to advance diagnostic quality systems, support regulatory inspections, and ensure investigational devices meet Gilead standards while protecting patient safety and data integrity.
  • The salary range for this position is: $210,375.00 - $272,250.00.

Matching Summary

Match Score: 85

Gilead Sciences is seeking a Director of R&D Diagnostics Quality to lead strategic quality initiatives and regulatory oversight for diagnostic programs within their global R&D portfolio. The ideal candidate will possess extensive experience in quality systems within the pharmaceutical or biotech industries, particularly in diagnostic roles, and will play a crucial role in ensuring compliance with medical device regulations.

Salary

Base: $210,375.00 - $272,250.00; Bonus/Equity: discretionary annual bonus, discretionary stock-based long-term incentives; Benefits: company-sponsored medical, dental, vision, and life insurance plans

Skills & Requirements

Must-have

  • strategic quality leadership
  • regulatory oversight for diagnostics
  • risk-based approach
  • vendor oversight
  • clinical evaluations
  • device governance
  • GxP compliance

Nice-to-have

  • elevate quality systems
  • patient-centric outcomes
  • health authority interaction
  • influence without authority

Key Requirements

  • PharmD/PhD with 8+ years' relevant experience OR MA/MS/MBA with 10+ years’ relevant experience OR BA/BS with 12+ years’ relevant experience
  • Experience in global quality systems
  • Experience in medical device quality
  • Experience in diagnostic quality role
  • Expertise in FDA 21 CFR 820/812/4, ISO 13485, ISO14971, EU MDR/IVDR, ICH, and GCPs

Work Rights

Not specified

Tailored Resume

Cover Letter