Sr IT Compliance Analyst

Role: IT Compliance Specialist supporting pharmaceutical manufacturing operations at Novo Nordisk's NC API facility. Responsibilities: develop and maintain validation/qualification documentation; conduct risk assessments; support project validation; ensure regulatory compliance; facilitate project transition to operations; participate in audits/inspections; collaborate with cross-functional teams to meet regulatory and quality standards; mentor personnel; contribute to process improvements. Requirements: Bachelor's in IT, Engineering, Science, or related field; 7+ years in IT compliance and 5+ years in validation/testing within pharma; proficiency in GxP, change management, deviation handling, incident/problem/change management; strong communication and problem-solving skills; MS Office expertise. Preferred: Master's degree; CISA certification; Lean Six Sigma Green/Black Belt; experience with audits, GxP, and life cycle management. High-value specifics: supporting pharma manufacturing, API production, compliance with regulatory standards, validation lifecycle, risk assessments, audits, and inspections. Collaboration: reports to Director/Associate Director, works with project teams and quality/validation groups. Work setup: on-site at NC facility, may require travel up to 10%, physical ability to move supplies and work in noise environments.