Director, Computer System Compliance

BeOne Medicines Ltd

Base: $172,500.00 - $232,500.00 annually; bonus/eq...
Computer system validation csa expertise
21 cfr part 11 and annex 11 compliance
Ai/ml system validation experience
This role serves as the technical expert leading Computer System Validation and Assurance while driving a shift to dynamic, risk-based assurance with a focus on AI-driven platforms

Job Summary

  • This role serves as the technical expert leading Computer System Validation and Assurance while driving a shift to dynamic, risk-based assurance with a focus on AI-driven platforms.
  • The position requires managing regulatory inspections for multiple international bodies including FDA, EMA, MHRA, and Health Canada within a GxP environment.
  • BeOne Medicines offers competitive compensation ranging from $172,500 to $232,500 annually along with comprehensive benefits including equity awards and a 401(k) plan.

Matching Summary

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

Salary

Base: $172,500.00 - $232,500.00 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 and Annex 11 compliance
  • AI/ML system validation experience
  • GAMP 5 methodology application
  • Cloud platform validation AWS Azure GCP

Nice-to-have

  • Generative AI implementation knowledge
  • Cross-functional team leadership skills
  • Agile and Waterfall project management
  • Continuous improvement mindset
  • Collaborative spirit in regulated environments

Key Requirements

  • Bachelor's degree required
  • 10+ years in Quality Assurance Compliance
  • 7+ years in software lifecycle methodologies
  • 2+ years focused on AI/ML or Advanced Analytics
  • Experience managing regulatory inspections

Work Rights

Not specified

Tailored Resume

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