Digital & Data Quality (ddq) Gmp Ai Compliance Director

Merck & Co., Inc., Rahway, NJ, USA

Rahway, New Jersey, USA
Base: $173,200.00 - $272,600.00; bonus/equity: ann...
Hybrid
Gmp/gdp ai compliance
Ai-based tools validation
Data management for ai
Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, and vendor assessment

Job Summary

  • Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, and vendor assessment.
  • Partner with stakeholders across manufacturing, R&D, and IT to develop common frameworks and champion common solutions.
  • Contribute to the DDQ strategy, team development, and continuous improvement of DDQ-owned processes as a member of the DDQ Leadership Team.

Matching Summary

Define and implement standards for GMP/GDP use of AI-based tools and applications, including data management, quality risk management, and vendor assessment.

Salary

Base: $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/GDP AI compliance
  • AI-based tools validation
  • Data management for AI
  • Quality risk management
  • Regulatory trends in AI

Nice-to-have

  • Cross-functional collaboration
  • External industry engagement
  • Experimentation with AI technologies
  • Leadership behaviors and values
  • Team development and coaching

Key Requirements

  • 12+ years global/site experience in regulated pharma/biologics manufacturing
  • Expert knowledge of FDA/EU/ICH/WHO regulations
  • Thorough understanding of GMP AI, data integrity, and computerized systems
  • Proven track record of validation strategies for novel technologies
  • Hands-on experience with AI technologies preferred

Work Rights

Not specified

Tailored Resume

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