Found 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.
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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