Sr. IT Compliance Analyst

Job requirements

• 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.

• 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 escalate.

• 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.

Job responsibilities

• 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.

Job benefits