IT Compliance Specialist
3 weeks ago
About the Role
We are seeking an IT Compliance Specialist to join our Site Collaboration Solutions team at Novo Nordisk A/S. As an IT Compliance Specialist, you will be responsible for ensuring that our IT systems meet regulatory requirements and are validated in line with our Quality Management System.
Key Responsibilities
- Perform computer system validation (CSV) and computer software assurance (CSA) activities in line with our QMS.
- Participate in audits and inspections, identifying and implementing solutions to compliance gaps.
- Manage yearly periodic review reports, update audit readiness checklists, and maintain system-level documentation.
- Develop and execute release plans, driving all release-related activities.
- Define test strategies, manage test execution, review, and report in line with the Software Testing Life Cycle (STLC).
- Develop and execute a risk-based validation strategy, acting as a subject matter expert for validation activities.
Requirements
- Bachelor's or Master's degree in a relevant field, with a minimum of 8-10 years of experience in the IT industry and 4+ years of GxP validation and CSV/testing experience.
- Experience in risk assessment, test management tools, supplier assessment, deviation handling, change management, and GAMP 5 and regulatory requirements.
- Expertise in performing complex validation activities, representing Novo Nordisk in relations with users and external stakeholders.
- Experience in Agile methodology, Azure DevOps, and automated test management tools.
- Excellent interpersonal and communication skills, representing Novo Nordisk in relations with users and external stakeholders.
- Minimum 5+ years of experience in performing RCAs, CAPA, and other relevant IT quality assurance activities.
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