Director, Computer System Compliance

beonemedicines.de

Base: $172,500.00 - $232,500.00 annually; bonus/eq...
Computer system validation/assurance
Risk-based compliance approaches
Ai/ml system validation
This role serves as the technical expert and lead for Computer System Validation/Assurance, focusing on transitioning to dynamic, risk-based assurance especially for AI-driven platforms

Job Summary

  • This role serves as the technical expert and lead for Computer System Validation/Assurance, focusing on transitioning to dynamic, risk-based assurance especially for AI-driven platforms.
  • The position involves managing multiple projects, performing audits, and collaborating closely with Quality and IT teams to maintain compliance with global regulations.
  • BeOne offers a comprehensive benefits package and promotes an inclusive, equitable work environment focused on delivering affordable medicines to patients worldwide.

Matching Summary

This role serves as the technical expert and lead for Computer System Validation/Assurance, focusing on transitioning to dynamic, risk-based assurance especially for AI-driven platforms.

Salary

Base: $172,500.00 - $232,500.00 annually; Bonus/Equity: Eligible for annual bonus or incentive compensation 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/Assurance
  • Risk-based compliance approaches
  • AI/ML system validation
  • GxP regulatory compliance
  • Software Development Lifecycle (SDLC)
  • Internal and external audit management
  • Cross-functional team leadership

Nice-to-have

  • Collaborative and motivated mindset
  • Continuous improvement focus
  • Effective communication skills
  • Mentoring and coaching abilities
  • Experience with cloud platforms AWS/Azure/GCP
  • Experience with automation and validation tools
  • Entrepreneurial and results-oriented

Key Requirements

  • 5+ years CSV/CSA experience
  • 7+ years software lifecycle and 21 CFR Part 11 compliance
  • 10+ years Quality Assurance/Compliance experience
  • Experience with GxP system validation
  • Bachelor’s degree with 10 years relevant experience
  • Experience managing regulatory inspections
  • Experience with AI/ML or Advanced Analytics validation

Work Rights

Not specified

Tailored Resume

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