Associate Director, Computer System Compliance

BeOne Medicines Ltd.

Base: $143,700.00 - $193,700.00 annually; bonus/eq...
Computer system validation csa expertise
21 cfr part 11 compliance knowledge
Ai/ml system validation experience
This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms

Job Summary

  • This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms.
  • The position requires managing multiple validation projects, developing standards for Generative AI integration, and ensuring compliance with cGxP regulations including 21 CFR Parts 11, 210, and 211.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and opportunities for equity awards and annual bonuses.

Matching Summary

This role serves as the technical expert leading Computer System Validation and Assurance while driving the shift to dynamic, risk-based assurance for AI-driven platforms.

Salary

Base: $143,700.00 - $193,700.00 annually; Bonus/Equity: Eligible for annual bonus plan and discretionary equity awards; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off

Skills & Requirements

Must-have

  • Computer System Validation CSA expertise
  • 21 CFR Part 11 compliance knowledge
  • AI/ML system validation experience
  • GAMP 5 methodology application
  • Cloud platform validation AWS Azure GCP
  • Cross-functional team leadership skills

Nice-to-have

  • Agile and Waterfall project management
  • Generative AI risk assessment skills
  • Continuous validation loop implementation
  • Python R SQL scripting understanding
  • Collaborative spirit and bold ingenuity

Key Requirements

  • 5+ years validation systems using Computer System Assurance methodologies
  • 7+ years software lifecycle methodologies and GxP validation
  • 2+ years focused on AI/ML or Advanced Analytics
  • Expert knowledge of GAMP 5 2nd Edition and EudraLex Annex 11
  • Experience validating enterprise systems on AWS Azure or GCP

Work Rights

Not specified

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