Director, Computer System Compliance

beonemedicines.ar

Base: $172,500.00 - $232,500.00 annually; bonus/eq...
Computer system validation/assurance
Risk-based compliance approaches
Ai-driven platform validation
This role serves as the technical expert and lead for Computer System Validation/Assurance and IT Compliance, driving transformation 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 Computer System Validation/Assurance and IT Compliance, driving transformation from static compliance to dynamic, risk-based assurance with a focus on AI-driven platforms.
  • The position offers a comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, Wellness, equity awards, and participation in the Employee Stock Purchase Plan.
  • BeOne Medicines is committed to fair and equitable compensation practices and an inclusive, equal opportunity work environment that values Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit.

Matching Summary

This role serves as the technical expert and lead for Computer System Validation/Assurance and IT Compliance, driving transformation 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: 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-driven platform validation
  • GxP regulatory compliance
  • 21 CFR Part 11 compliance
  • Software Development Lifecycle (SDLC)
  • Internal and external audit management

Nice-to-have

  • Collaborative cross-functional teamwork
  • Continuous improvement mindset
  • Mentoring and talent development
  • Effective communication skills
  • Experience with cloud platforms AWS Azure GCP
  • Experience with automated testing tools
  • Entrepreneurial and results-oriented mindset

Key Requirements

  • 5+ years CSV/CSA experience
  • 7+ years software lifecycle methodologies
  • 2+ years AI/ML or Advanced Analytics focus
  • 10+ years Quality Assurance/Compliance experience
  • Experience managing regulatory inspections
  • Bachelor’s degree with 10 years relevant experience
  • Experience with GAMP 5 and regulatory standards

Work Rights

Not specified

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