Sr IT Compliance Analyst
Novo Nordisk
June 29, 2026
On-site
Clayton, NC
IT
What We Offer You
- 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
The Position
Provide subject matter expertise in IT compliance, process improvement, and IT compliance service delivery management across the site. Ensure IT solutions are compliant with relevant regulations and standards and facilitate seamless transition/handover of projects to service operations with key stakeholders. Enable governance and continuous improvement supporting product quality, patient safety, and data integrity.
Essential Functions
- Develop and maintain validation and qualification documentation
- Conduct risk assessments and impact analyses; develop mitigation strategies
- Guide project teams on validation and qualification requirements
- Monitor and improve documentation/processes for regulatory compliance and Novo Nordisk standards
- Facilitate project transition/handover to service operations
- Maintain system documentation/processes in compliance with standards and regulatory requirements
- Serve as IT SME in audits and inspections; provide documentation of validated state and life-cycle management
- Collaborate cross-functionally to meet business needs, timelines, budget, documentation, and life-cycle management
- Provide leadership/expertise in IT compliance, process improvement, and project coordination
- Coach/mentor personnel; participate in process group meetings
- Follow safety and environmental requirements; other duties as assigned
Qualifications
- Bachelor’s degree in IT, Engineering, Science, or relevant field (required)
- Master’s degree (preferred)
- 7+ years IT compliance experience (required), preferably pharma
- 5+ years validation/testing of IT solutions (required), preferably pharma
- CISA (preferred); Lean Six Sigma Green/Black Belt (preferred)
- SME audit/inspection experience (preferred)
- GxP, change management, deviation handling (preferred)
- Incident, Problem, and Change Management in IT (preferred)
- Excellent English writing/communication (required)
- Customer service/team collaboration (required)
- Problem solving, negotiation/conflict management, interpersonal skills (required)
- Planning/organization/decision-making; handle complexity/ambiguity (required)
- Strong computer skills and MS Office Expert (required)
- 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
The Position
Provide subject matter expertise in IT compliance, process improvement, and IT compliance service delivery management across the site. Ensure IT solutions are compliant with relevant regulations and standards and facilitate seamless transition/handover of projects to service operations with key stakeholders. Enable governance and continuous improvement supporting product quality, patient safety, and data integrity.
Essential Functions
- Develop and maintain validation and qualification documentation
- Conduct risk assessments and impact analyses; develop mitigation strategies
- Guide project teams on validation and qualification requirements
- Monitor and improve documentation/processes for regulatory compliance and Novo Nordisk standards
- Facilitate project transition/handover to service operations
- Maintain system documentation/processes in compliance with standards and regulatory requirements
- Serve as IT SME in audits and inspections; provide documentation of validated state and life-cycle management
- Collaborate cross-functionally to meet business needs, timelines, budget, documentation, and life-cycle management
- Provide leadership/expertise in IT compliance, process improvement, and project coordination
- Coach/mentor personnel; participate in process group meetings
- Follow safety and environmental requirements; other duties as assigned
Qualifications
- Bachelor’s degree in IT, Engineering, Science, or relevant field (required)
- Master’s degree (preferred)
- 7+ years IT compliance experience (required), preferably pharma
- 5+ years validation/testing of IT solutions (required), preferably pharma
- CISA (preferred); Lean Six Sigma Green/Black Belt (preferred)
- SME audit/inspection experience (preferred)
- GxP, change management, deviation handling (preferred)
- Incident, Problem, and Change Management in IT (preferred)
- Excellent English writing/communication (required)
- Customer service/team collaboration (required)
- Problem solving, negotiation/conflict management, interpersonal skills (required)
- Planning/organization/decision-making; handle complexity/ambiguity (required)
- Strong computer skills and MS Office Expert (required)