IT Risk and Vendor Compliance Analyst

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.