IT Compliance and Validation Manager
2 weeks ago
Job Overview
Novo Nordisk is a leading global healthcare company with a strong legacy in diabetes care. We are growing rapidly and expanding our commitment to defeat serious chronic diseases, impacting millions of patient lives daily.
We recognize the importance of collaboration and joint potential among our employees worldwide. As an IT Validation and Compliance Specialist I, you will have a unique opportunity to work towards something bigger than yourself.
Responsibilities:
- Perform Computer System Validation (CSV) and Computer Software Assurance (CSA) activities in line with Novo Nordisk's Quality Management System (QMS)
- Define risk-based validation strategies and execute them according to QMS guidelines
- Act as a Subject Matter Expert (SME) for validation activities, executing strategies in Agile and V Model methodologies as necessary
- Manage test execution, review, and reporting in line with the Software Testing Life Cycle (STLC), including handling validation deviations
- Participate in audits and inspections, finding solutions to compliance gaps identified during these events
- Provide compliance consulting for IT activities and end-to-end service delivery management of assigned/owned services
Requirements:
- Bachelor's or Master's degree in a relevant field with at least 6+ years of experience in a service-based organization/pharmaceutical industry, preferably in the IT quality domain
- Industry-recognized ITIL and ISO quality management certification preferred
- Minimum 4 years of practical experience in GxP areas with exposure to regulatory affairs and 2+ years of performing Root Cause Analysis (RCA), CAPA, and other relevant IT quality activities
- Experience in Risk assessment (IT RA, Quality, Functional, DI, Supplier) and exposure to Test management tools such as HP ALM
- Knowledge of both waterfall and Agile methodologies, supplier assessment, deviation handling, change management, GAMP 5, and various regulatory requirements including CFR part 11 and EU Annex 11
Estimated Salary: $120,000 - $180,000 per year, depending on location and experience.
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