IT System Manager II
Novo Nordisk
15 days ago
Remote friendly (Clayton, NC)
United States
IT
What We Offer You
- Leading pay and annual performance bonus
- Generous paid time off including 14 paid holidays
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus individual company match option
- Family-focused benefits (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
- Manage IT systems across the lifecycle; provide project oversight and drive deliverables.
- Ensure adherence to Novo Nordisk and regulatory requirements (GxP, financial, personal data protection).
- Ensure processes for system maintenance/operation and regulatory compliance.
Essential Functions
- Ensure system compliance with internal SOPs and external requirements (e.g., 21 CFR Part 11, personal data protection, Sarbanes-Oxley).
- Maintain IT CSV validation and system decommissioning documentation.
- Perform system lifecycle management; contribute to the IT roadmap.
- Document and manage operation/maintenance (incident mgmt, SLA/contract mgmt, data integrity/retention/archive, continuity/recovery).
- Conduct system reviews and ensure testing/qualification is in place (FAT, SAT, UAT, IQ/OQ/PQ, and/or GEP).
- Support root-cause analysis, corrective actions, and audits/inspections; act as escalation point for support.
- Maintain required system documentation; manage security/access; approve access changes; annual system evaluation.
Qualifications / Required Skills
- Bachelor’s degree in CS/Engineering or related technical field.
- 5+ years’ IT operations & maintenance (preferably pharma).
- Experience with production manufacturing; IT projects and system management.
- Knowledge of COBIT, ITIL, GAMP, 21 CFR Part 11, and/or PIC/S Annex 11; GxP documentation; validation/system lifecycle; manufacturing process areas (aseptic, inspection, assembly, packaging, utilities, labs); regulatory audits.
- Strong written/oral communication; root-cause analysis expertise; ability to plan/organize and lead cross-functional problem resolution.
Application Instructions
- For application accommodations, call 1-855-411-5290 (accommodation requests only).
- Leading pay and annual performance bonus
- Generous paid time off including 14 paid holidays
- Health, dental, and vision insurance (effective day one)
- Guaranteed 8% 401(k) contribution plus individual company match option
- Family-focused benefits (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
- Manage IT systems across the lifecycle; provide project oversight and drive deliverables.
- Ensure adherence to Novo Nordisk and regulatory requirements (GxP, financial, personal data protection).
- Ensure processes for system maintenance/operation and regulatory compliance.
Essential Functions
- Ensure system compliance with internal SOPs and external requirements (e.g., 21 CFR Part 11, personal data protection, Sarbanes-Oxley).
- Maintain IT CSV validation and system decommissioning documentation.
- Perform system lifecycle management; contribute to the IT roadmap.
- Document and manage operation/maintenance (incident mgmt, SLA/contract mgmt, data integrity/retention/archive, continuity/recovery).
- Conduct system reviews and ensure testing/qualification is in place (FAT, SAT, UAT, IQ/OQ/PQ, and/or GEP).
- Support root-cause analysis, corrective actions, and audits/inspections; act as escalation point for support.
- Maintain required system documentation; manage security/access; approve access changes; annual system evaluation.
Qualifications / Required Skills
- Bachelor’s degree in CS/Engineering or related technical field.
- 5+ years’ IT operations & maintenance (preferably pharma).
- Experience with production manufacturing; IT projects and system management.
- Knowledge of COBIT, ITIL, GAMP, 21 CFR Part 11, and/or PIC/S Annex 11; GxP documentation; validation/system lifecycle; manufacturing process areas (aseptic, inspection, assembly, packaging, utilities, labs); regulatory audits.
- Strong written/oral communication; root-cause analysis expertise; ability to plan/organize and lead cross-functional problem resolution.
Application Instructions
- For application accommodations, call 1-855-411-5290 (accommodation requests only).