Director, Computer System Compliance

BeOne Medicines Ltd

Base: $172,500.00 - $232,500.00 annually; bonus/eq...
Computer system validation csa methodologies
21 cfr part 11 and annex 11 compliance
Ai/ml system validation experience
This role serves as the technical expert leading the transition from static paper-heavy compliance to dynamic risk-based assurance for AI-driven platforms

Job Summary

  • This role serves as the technical expert leading the transition from static paper-heavy compliance to dynamic risk-based assurance for AI-driven platforms.
  • The position requires managing multiple computer system validation projects while ensuring alignment with global standards and regulatory bodies like FDA and EMA.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), and discretionary equity awards for all employees.

Matching Summary

This role serves as the technical expert leading the transition from static paper-heavy compliance to dynamic risk-based assurance for 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, Wellness

Skills & Requirements

Must-have

  • Computer System Validation CSA methodologies
  • 21 CFR Part 11 and Annex 11 compliance
  • AI/ML system validation experience
  • GAMP 5 second edition expertise
  • Cloud platform validation AWS Azure GCP
  • Internal audit management and execution
  • Cross-functional team leadership

Nice-to-have

  • Generative AI and LLM risk assessment
  • Continuous validation loop implementation
  • Agile and Waterfall project approaches
  • Automated testing tool proficiency
  • Python R or SQL data pipeline auditing
  • Global regulatory body inspection experience
  • Collaborative spirit and bold ingenuity

Key Requirements

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

Work Rights

Not specified

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