The role provides independent quality oversight of Gilead's extensive global manufacturing and supply network by leading GMP and GDP audits
Job Summary
The role provides independent quality oversight of Gilead's extensive global manufacturing and supply network by leading GMP and GDP audits.
Candidates must manage the end-to-end audit lifecycle including planning, execution, reporting, and assessment of corrective actions.
This position offers a competitive salary range of $165,495.00 to $214,170.00 along with discretionary bonuses and comprehensive benefits.
Matching Summary
The role provides independent quality oversight of Gilead's extensive global manufacturing and supply network by leading GMP and GDP audits.
Salary
Base: $165,495.00 - $214,170.00; Bonus/Equity: Discretionary annual bonus and stock-based incentives available; Benefits: Medical, dental, vision, life insurance, and paid time off
Skills & Requirements
Must-have
GMP and GDP audit experience
Global regulatory requirements knowledge
Risk-based audit strategy execution
Cross-functional stakeholder partnership
50% travel requirement
Nice-to-have
Leadership and team development skills
Experience with biologics and medical devices
Continuous improvement initiative support
Strong written communication abilities
Key Requirements
Bachelor's degree plus 10 years experience OR Master's plus 8 years OR PhD/PharmD plus 5 years
Demonstrated experience in biotechnology or pharmaceutical industry
Proven track record as an independent GMP/GDP auditor
In-depth knowledge of 21 CFR Parts 210/211 and EU EudraLex Volume 4