What We Offer You:
- Leading pay and annual performance bonus for all positions
- Generous paid time off including 14 paid holidays
- Health Insurance, Dental Insurance, Vision Insurance β 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 comply with relevant regulations and standards; facilitate seamless transition and handover of projects to service operations with key stakeholders. Support governance and continuous improvement to enable 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/qualification requirements
- Monitor and improve documentation and processes for regulatory and Novo Nordisk standards
- Facilitate project transition/handover to service operations
- Maintain system documentation/processes in compliance with standards
- Serve as IT SME in audits/inspections; provide documentation for validated state across lifecycle
- Collaborate cross-functionally to deliver on time/budget with proper documentation
- Provide leadership in IT compliance, process improvement, and project coordination
- Coach/mentor personnel; participate in process group meetings
- Follow all safety & environmental requirements
Qualifications:
- Bachelorβs degree in IT, Engineering, Science, or relevant field (required)
- Masterβs degree (preferred)
- 7+ years IT compliance experience (required; preferably pharma)
- 5+ years validation and testing of IT solutions (required; preferably pharma)
- CISA (preferred)
- Lean Six Sigma Green Belt/Black Belt (preferred)
- Audit/inspection SME experience (preferred)
- GxP, change management, deviation handling; Incident/Problem/Change Mgmt in IT (preferred)
- Excellent writing/communication in English (required)
- Customer service, collaboration, problem-solving, negotiation/conflict management, planning/organizing, and strong MS Office skills (required)