Sr. IT Compliance Analyst

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 deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

The Sr. IT Compliance Analyst is the senior individual contributor responsible for the operational execution of Liquidia's IT compliance program in a commercial-stage public pharmaceutical environment subject to SOX, GxP, and 21 CFR Part 11 regulations. The role serves as the primary IT bridge to the Quality function on compliance and computerized system validation matters, plans and conducts internal IT audits, manages supplier and third-party IT risk assessments, oversees the IT Infrastructure Qualification program for GxP-supporting infrastructure, serves as the primary IT liaison for external audit engagements, drives corrective action closure, and leads the maturation of the IT cybersecurity framework on a multi-year roadmap. The role contributes to the broader IT cybersecurity program through coordination on policy lifecycle, AI governance documentation, and risk register maintenance. This position establishes operational separation of duty between IT compliance oversight and IT security and infrastructure execution.

Education and Experience

• Minimum of 8 years of progressive experience in IT compliance, IT audit, or governance, risk, and compliance (GRC) functions with a Bachelor's degree, or a minimum of 6 years with a Master's degree, in Information Technology, Business, Accounting, or a related discipline.
• Demonstrated experience in the pharmaceutical, biotechnology, or life sciences industry preferred.
• Working knowledge of IT-relevant Good Practice (GxP) regulations, including United States (FDA) requirements and 21 CFR Part 11.
• Working knowledge of GAMP 5 methodology and IT infrastructure qualification practices.
• Demonstrated experience supporting external audits and managing corrective action lifecycles.

Knowledge, Skills and Abilities

• Strong working knowledge of SOX IT General Controls, including access management, change management, and operational controls in support of financial reporting.
• Familiarity with industry-recognized cybersecurity frameworks and tiered adoption approaches.
• Professional certifications such as CISA, CRISC, CISM, or equivalent preferred.
• Strong technical writing skills suitable for compliance and qualification documentation.
• Excellent written and verbal communication skills across IT, Quality, senior leadership, and external auditors.
• Capable of independent decision‑making on compliance matters within defined scope, with sound judgment on when to mandation mandatory mandation mandatory.
• Demonstrated ability to influence control owners without direct management authority.
• Experience with eQMS platforms and audit management tools (AuditBoard, Veeva, or comparable) preferred.
• Proficient in MS Office.

• Steward the lifecycle of IT policies, standards, and standard operating procedures, including version control, periodic review, and stakeholder approval workflows.
• Maintain the IT risk register, governance trackers, and recurring control evidence, including quarterly review cadences.
• Maintain AI governance documentation, including tool authorization records and monitoring artifacts.
• Administer SOX IT General Controls (ITGC) documentation, evidence collection, and control performance tracking.
• Coordinate ITGC walkthroughs, testing, and evidence requests with internal and external auditors, ensuring timely delivery of requested artifacts.
• Track IT audit findings and corrective actions through verified closure with control owners.
• Maintain 21 CFR Part 11 documentation for IT‑managed systems and coordinate with Quality on validation boundaries.
• Support infrastructure qualification activities for GxP-supporting infrastructure using established IT qualification templates, in coordination with Quality and the Computer System Validation function.
• Participate in change control and periodic review activities for validated and qualified IT systems to assess compliance impact.
• Maintain cybersecurity framework alignment documentation and support gap analysis and remediation tracking.
• Conduct third‑party IT risk assessments in coordination with Procurement and Legal.
• Support security awareness training compliance reporting and incident response documentation.
• Perform other duties as assigned.