Digital & Data Quality (ddq) Gmp Ai Compliance Director

microsatsystems.biz

Base: $173,200.00 - $272,600.00; bonus/equity: eli...
Hybrid (3 days on-site, 1 day remote)
Gmp/gdp ai compliance standards
Ai validation and monitoring policies
Quality oversight of ai tools
The Digital & Data Quality (DDQ) GMP AI Compliance Director position at microsatsystems.biz requires an experienced candidate to oversee the implementation of AI-based tools and ensure compliance with regulatory standards in a biopharmaceutical setting. The role emphasizes collaboration across divisions, the development of policies, and active engagement in industry benchmarking

Job Summary

  • Define and implement standards for GMP/GDP use of AI-based tools and applications.
  • Partner with relevant stakeholders across manufacturing, R&D, and IT to develop common frameworks.
  • The salary range for this role is $173,200.00 - $272,600.00.

Matching Summary

Match Score: 85

The Digital & Data Quality (DDQ) GMP AI Compliance Director position at microsatsystems.biz requires an experienced candidate to oversee the implementation of AI-based tools and ensure compliance with regulatory standards in a biopharmaceutical setting. The role emphasizes collaboration across divisions, the development of policies, and active engagement in industry benchmarking.

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

Must-have

  • GMP/GDP AI compliance standards
  • AI validation and monitoring policies
  • Quality oversight of AI tools
  • Regulatory trends in AI use
  • Data integrity and quality management

Nice-to-have

  • Collaborative leadership style
  • External industry engagement
  • Experimentation with AI technologies
  • Adaptability and decisiveness
  • Coaching and team building

Key Requirements

  • 12 years global and site experience
  • Bachelor's degree in Science, IT, Engineering or equivalent
  • Expert knowledge of FDA/EU/ICH/WHO regulations
  • Thorough understanding of GMP AI trends
  • Extensive knowledge of quality risk management

Work Rights

Not specified

Tailored Resume

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