Job Summary

• Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations.
• Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, vendor assessment, human-in-the-loop role, technology-specific requirements, data retention, and periodic monitoring.
• The salary range for this role is $173,200.00 - $272,600.00.

Matching Summary

Salary

Base: $173,200.00 - $272,600.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• 12 years global/site experience
• FDA/EU regulated manufacturing
• Expert knowledge of regulations
• Thorough understanding of GMP AI trends
• Extensive knowledge of quality risk management
• Proven track record of validation strategies

Work Rights