Director, Computer System Compliance

BeiGene

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 while ensuring all resource expenditures align with budgets and providing input to Software Development Lifecycle processes.
  • BeOne offers a comprehensive benefits package including medical, dental, vision, 401(k), life insurance, paid time off, and opportunities for 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

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
  • Risk-based assurance approaches

Nice-to-have

  • Generative AI and LLM implementation knowledge
  • Agile and Waterfall project management
  • Cross-functional team leadership skills
  • Continuous improvement culture mindset
  • Python R or SQL scripting understanding
  • Global regulatory body interaction experience

Key Requirements

  • Bachelor's degree required
  • 10+ years in Quality Assurance Compliance
  • 7+ years in software lifecycle methodologies
  • 5+ years validation systems using CSA
  • 2+ years focused on AI ML or Advanced Analytics
  • Experience managing regulatory inspections for FDA EMA MHRA Health Canada

Work Rights

Not specified

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