Digital & Data Quality (ddq) Gmp Ai Compliance Director

Mdcrecruiting

Base: $173,200.00 - $272,600.00; bonus/equity: eli...
Hybrid
Gmp ai compliance
Regulatory trend monitoring
Validation of ai tools
We aspire to be the premier research-intensive biopharmaceutical company advancing health solutions for people and animals

Job Summary

  • We aspire to be the premier research-intensive biopharmaceutical company advancing health solutions for people and animals.
  • The role involves defining standards and leading validation strategies for AI-based tools in GMP/GDP environments while partnering with multiple divisions.
  • We offer a comprehensive benefits package including medical, dental, vision, retirement plans, paid holidays, and vacation.

Matching Summary

We aspire to be the premier research-intensive biopharmaceutical company advancing health solutions for people and animals.

Salary

Base: $173,200.00 - $272,600.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive medical, dental, vision, retirement, paid holidays, vacation

Skills & Requirements

Must-have

  • GMP AI compliance
  • Regulatory trend monitoring
  • Validation of AI tools
  • Quality risk management
  • Cross-functional collaboration
  • Data integrity management

Nice-to-have

  • Collaborative leadership style
  • Training and coaching skills
  • Experience in culturally diverse environments
  • Industry collaboration
  • Lean Six Sigma or PMP certification
  • Analytical problem-solving

Key Requirements

  • Bachelor's degree in Science or IT or Engineering
  • 12+ years FDA/EU regulated pharma manufacturing experience
  • Expert knowledge of FDA/EU/ICH/WHO regulations
  • Proven validation strategy implementation
  • Hands-on AI technology experience preferred
  • Experience leading regulatory inspections
  • Ability to travel 25%

Work Rights

US and Puerto Rico Residents Only

Tailored Resume

Cover Letter