Sr IT Compliance Analyst

About the role

The Sr IT Compliance Analyst provides subject matter expertise in IT compliance, process improvement, and IT compliance service delivery management across the site. They ensure IT solutions are compliant with relevant regulations and standards and facilitate the seamless transition and handover of projects to service operations with key stakeholders.

Responsibilities

• Develop and maintain validation and qualification documentation
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
• Collaborate with cross-functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
• Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT compliance, process improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Requirements

• Bachelor’s Degree in IT, Engineering, Science, or relevant field of study from an accredited university required
• Minimum of seven (7) years of experience in IT compliance required, preferably within the pharmaceutical industry
• Minimum of five (5) years of experience on Validation and Testing of IT Solutions required, preferably within the pharmaceutical industry
• Certified Information Systems Auditor (CISA) is preferred
• Lever Six Sigma Green Belt or Black Belt is preferred
• Experience as SME participating in Audits and Inspections preferred
• Experience on GxP, change management and deviation handling preferred
• Experience with Incident, Problem, and Change Management in IT preferred
• Excellent writing and communication skills, in English required
• Excellent customer service skills and ability to collaborate effectively in a team environment required
• Excellent problem solving, negotiation, conflict management, and interpersonal skills required
• Excellent planning, organizing, decision making and deal with complexity and ambiguity required
• Strong computer skills and MS Office Expert required