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.