Director, Computer System Compliance

BeOne

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 Computer System Validation and Assurance with a specific focus on AI-driven platforms

Job Summary

  • This role serves as the technical expert leading Computer System Validation and Assurance with a specific focus on AI-driven platforms.
  • The position requires managing multiple 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 to all employees.

Matching Summary

This role serves as the technical expert leading Computer System Validation and Assurance with a specific 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, 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 2nd 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 auditing skills
  • Collaborative spirit and bold ingenuity
  • Global regulatory body inspection experience

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

Tailored Resume

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