Associate Director, It Validation

Sarepta Therapeutics

United States
Base: $160,800 - $201,000 py; bonus/equity: not sp...
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Gxp computerized system validation
Risk-based validation strategies
21 cfr part 11 compliance
** Sarepta Therapeutics is seeking an Associate Director of IT Validation to lead computer system validation (CSV) and computerized system assurance (CSA) activities within their R&D and Technical Operations. The ideal candidate will possess significant experience in the life sciences sector, especially in GxP compliance, and will play a vital role in ensuring that systems meet regulatory standards while supporting innovative genetic medicine initiatives. **

Job Summary

  • The role involves leading CSV/CSA activities to ensure GxP computerized systems are implemented and maintained in compliance with FDA, EMA, and ICH requirements.
  • Sarepta Therapeutics offers a culture that supports work-life integration and provides comprehensive benefits for physical, emotional, and financial wellness.
  • Candidates will partner with IT, business owners, and Quality Assurance to drive risk-based validation strategies and support regulatory inspections.

Matching Summary

Match Score: 75

** Sarepta Therapeutics is seeking an Associate Director of IT Validation to lead computer system validation (CSV) and computerized system assurance (CSA) activities within their R&D and Technical Operations. The ideal candidate will possess significant experience in the life sciences sector, especially in GxP compliance, and will play a vital role in ensuring that systems meet regulatory standards while supporting innovative genetic medicine initiatives. **

Salary

Base: $160,800 - $201,000 per year; Bonus/Equity: Not specified; Benefits: Comprehensive package including wellness and caregiver support

Skills & Requirements

Must-have

  • GxP computerized system validation
  • Risk-based validation strategies
  • 21 CFR Part 11 compliance
  • EU Annex 11 regulatory knowledge
  • Veeva and Oracle system experience
  • Polarion ALM administration

Nice-to-have

  • AI/ML tools in regulated space
  • NIST and ISO security frameworks
  • SOC 2 infrastructure qualification
  • Proactive self-starting mindset
  • Cross-functional communication skills

Key Requirements

  • 8+ years in clinical/commercial pharma or biotech
  • Bachelor's or Master's degree in relevant field
  • Must be authorized to work in the U.S.

Work Rights

Must be authorized to work in the U.S.

Tailored Resume

Cover Letter