Job Description

Required Qualifications

  • Bachelor’s degree in Information Technology, Computer Science, Engineering, Quality, or a related field
  • 8+ years of experience in IT Quality & Compliance, IT Risk Management or Vendor Oversight within a regulated environment (pharma, biotech, medical devices, or similar)
  • Strong working knowledge of:
  • FDA QMSR / 21 CFR Part 820
  • 21 CFR Part 11
  • ISO 13485 and ISO 9001
  • Data Integrity principles (ALCOA+)
  • Hands‑on experience supporting vendor‑hosted and SaaS systems in GxP contexts.
  • Experience leading or supporting vendor audits.
  • Familiarity with information security frameworks (e.g., ISO 27001, SOC 2).
  • Experience working with cloud‑based systems and modern IT delivery models
  • Demonstrated experience partnering with Information Security teams.


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