Sr. IT Compliance Analyst (GxP)

Role: Lead IT compliance efforts within a biopharma environment, focusing on regulatory adherence and validation of GxP systems. Responsibilities: manage IT policies, risk registers, and audit preparations; oversee SOX ITGC, 21 CFR Part 11 compliance, infrastructure qualification, and cybersecurity frameworks; coordinate internal/external audits and corrective actions; support validation activities and risk assessments for GxP-supporting infrastructure; ensure cybersecurity policies and incident response align with GxP requirements. Requirements: 8+ years in IT compliance, audit, or GRC in pharma/biotech; Bachelor's in IT, Business, or related field (Master's preferred); strong knowledge of FDA GxP, 21 CFR Part 11, GAMP 5, and SOX controls; experience supporting audits and managing corrective actions; certifications like CISA, CRISC, or CISM preferred. High-Value: pharmaceutical/biotech industry, GxP regulations, 21 CFR Part 11, SOX, GAMP 5, GxP validation, cybersecurity, external audit support, infrastructure qualification. WorkSetup: Not specified; likely hybrid or on-site based on industry norms.