Sr IT Compliance Analyst

Novo Nordisk • Clayton, NC

22h • Onsite

About The Position

Provide subject matter expertise in IT compliance, process improvement and IT compliance service delivery management across the site. Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders. Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization's goals of improving the lives of people with chronic diseases.

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
• 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

Nice To Haves

• Master’s degree in IT, Engineering, Science, or relevant field of study from an accredited university preferred
• Certified Information Systems Auditor (CISA) is preferred
• Lean 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

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

Benefits

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior