Digital & Data Quality (ddq) Gmp Ai Compliance Director

Merck Sharp & Dohme Corp

$173,200.00 - $272,600.00; bonus/equity: annual bo...
Hybrid
Gmp ai compliance
Data management standards
Regulatory trends ai
Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations

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

Keep abreast of emerging regulatory trends pertaining to AI use in GMP/GDP operations.

Salary

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

Skills & Requirements

Must-have

  • GMP AI compliance
  • data management standards
  • regulatory trends AI
  • validation strategies AI
  • quality oversight AI

Nice-to-have

  • collaborative leadership style
  • adaptability and decisiveness
  • external engagement benchmarking
  • experiment with AI technologies

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

Work Rights

Not specified

Tailored Resume

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