Establish, maintain, and continuously improve the company’s IT quality, risk, and vendor compliance framework
Ensure IT systems and third‑party vendors supporting regulated processes are fit for intended use
Lead the identification, assessment, and mitigation of IT and technology‑related risks
Define and maintain a risk‑based approach to IT governance aligned with applicable regulations
Support system risk assessments for new tools, enhancements, upgrades, and decommissioning activities
Lead IT system and vendor risk assessments from a quality and regulatory perspective
Ensure risks impacting GxP compliance, data integrity, and patient/product safety are assessed and mitigated
Lead vendor risk assessments, due diligence activities, and ongoing monitoring for critical and high‑risk vendors
Partner with InfoSec to align vendor quality risk assessments
Review and assess vendor documentation and coordinate vendor audits
Support internal audits, regulatory inspections, and third‑party assessments related to IT systems and vendors
Partner closely with IT, Quality, InfoSec, and Business teams to enable compliant technology adoption

10+ years IT Risk and Vendor Compliance experience
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
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

Associate Lead Consultant – Validation Testing

Key skills