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 and lead for driving changes in the CSV/CSA domain by moving from static compliance to dynamic risk-based assurance with a focus on AI-driven platforms

Job Summary

  • This role serves as the technical expert and lead for driving changes in the CSV/CSA domain by moving from static compliance to dynamic risk-based assurance with a focus on AI-driven platforms.
  • The position requires managing multiple computer system validation projects, ensuring resource expenditures align with budgets, and providing input to Software Development Lifecycle processes including continuous validation loops.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), life insurance, paid time off, and opportunities for discretionary equity awards.

Matching Summary

This role serves as the technical expert and lead for driving changes in the CSV/CSA domain by moving from static compliance to dynamic risk-based assurance with a focus on AI-driven platforms.

Salary

Base: $172,500.00 - $232,500.00 annually; Bonus/Equity: Annual bonus plan eligible; Equity: Discretionary stock awards available; Benefits: Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, PTO

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
  • Regulatory inspection management FDA EMA MHRA

Nice-to-have

  • Generative AI and LLM risk assessment
  • Agile and Waterfall lifecycle approaches
  • Cross-functional team leadership skills
  • Continuous improvement mindset
  • Collaborative spirit and bold ingenuity

Key Requirements

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

Work Rights

Not specified

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