Senior IT Compliance & GxP Audit Lead

Clutch Canada; United States; On-site; USD 110,000 - 165,000; Full time

Job summary

Liquidia is seeking a Sr. IT Compliance Analyst to lead IT compliance activities in a commercial-stage pharmaceutical setting governed by SOX, GxP, and 21 CFR Part 11.

You will partner with Quality to validate systems, drive internal audits, manage third-party risk, and advance the cybersecurity framework on a multi-year roadmap. Key responsibilities include coordinating ITGCs, maintaining risk registers, supporting AI governance documentation, and ensuring timely closure of audit findings while

Qualifications

• Minimum 8 years of IT compliance, IT audit, or GRC experience with a Bachelor's degree, or 6 years with a Master's degree.
• Pharmaceutical, biotech, or life sciences familiarity is preferred.
• Knowledge of FDA requirements and 21 CFR Part 11.

Responsibilities

• Lead operational IT compliance activities in a SOX/GxP regulated environment.
• Conduct internal IT audits and coordinate with external auditors.
• Manage supplier/third-party IT risk assessments and ITGCs.
• Maintain IT risk registers and evidence for audits.
• Coordinate AI governance documentation and policy lifecycle.

Skills

SOX ITGC

IT Audit

GxP regulations

Documentation writing

Stakeholder communication

Decision making

Education

Bachelor's degree in Information Technology, Business, Accounting, or related discipline

Master's degree preferred

Tools

AuditBoard

Veeva

eQMS platforms

MS Office

Job description

Liquidia is seeking a Sr. IT Compliance Analyst to lead IT compliance activities in a commercial-stage pharmaceutical setting governed by SOX, GxP, and 21 CFR Part 11.

You will partner with Quality to validate systems, drive internal audits, manage third-party risk, and advance the cybersecurity framework on a multi-year roadmap. Key responsibilities include coordinating ITGCs, maintaining risk registers, supporting AI governance documentation, and ensuring timely closure of audit findings while