Director, Computer System Compliance

beigene.se

$172,500.00 - $232,500.00 annually; bonus/equity: ...
Computer system validation/assurance
Data integrity
It compliance
This position will serve as the technical expert and lead for Computer System Validation/Computer System Assurance, (CSV/CSA) Data Integrity & IT Compliance for IT Systems

Job Summary

  • This position will serve as the technical expert and lead for Computer System Validation/Computer System Assurance, (CSV/CSA) Data Integrity & IT Compliance for IT Systems.
  • The individual will be responsible for driving changes in the CSV/CSA domain by moving from static and paper-heavy compliance to dynamic and risk-based assurance with a specific focus on AI-driven platforms.
  • The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Matching Summary

This position will serve as the technical expert and lead for Computer System Validation/Computer System Assurance, (CSV/CSA) Data Integrity & IT Compliance for IT Systems.

Salary

$172,500.00 - $232,500.00 annually; Bonus/Equity: Eligible for annual bonus plan; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Computer System Validation/Assurance
  • Data Integrity
  • IT Compliance
  • AI-driven platforms
  • cGxP, CFR 21 Parts 11
  • GAMP 5
  • Risk-based approaches

Nice-to-have

  • Collaborative
  • Scientific and business professionals
  • Continuous improvement
  • Engaged and effective work environment

Key Requirements

  • 5+ years validation systems using Computer System Assurance
  • 7+ years software lifecycle methodologies, 21CFR Part 11 compliance, GxP
  • 2+ years focused on AI/ML or Advanced Analytics
  • 10+ years Quality Assurance / Compliance
  • Bachelor’s degree with minimum 10 years of relevant work experience
  • Experience managing regulatory inspections

Work Rights

Not specified

Tailored Resume

Cover Letter