Novo Nordisk · 6 hours ago
IT System Manager III - Multiple Openings
Clayton, NC
Full-time
Onsite
Senior Level
7+ years expNovo Nordisk is a global healthcare company dedicated to defeating chronic diseases. They are seeking an IT System Manager III to manage systems throughout their lifecycle, provide project oversight, and ensure compliance with regulatory requirements for assigned IT systems.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)
Reviews & maintains all IT CSV validation/system decommissioning documentation in accordance to regulatory & Novo Nordisk requirements
Responsible for the system life cycle management & suggests inputs for the IT roadmap
Documents operation & maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity/recovery plans)
Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system
Acts as a peer mentor & lead in reviewing documentation prepared by team members
Review & approves testing protocols to ensure requirements are tested appropriately
Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
Audit & inspection support
System documentation including operational manuals, system architecture, & data flow completion
Works with subject matter expert (SME) to ensure system documentation is in compliance with local, corporate & regulatory regulations
Documentation of system configuration baselines
Approves appropriate access to new users & removes access as necessary
Works with IT Security/SME to ensure controls are in place & documented
Performs annual system evaluation
Serves as the escalation point for system support
Ensures end user training is in place, as required
Prepares support agreements with internal & external sources
Ability to lead projects & project teams as needed. Performs activities assigned within agreed timelines
Other accountabilities, as assigned
Qualification
Required
Bachelor's Degree in Computer Science or Engineering, or similar applicable technical degree in relevant field required
Minimum seven (7) years of operation & maintenance of IT systems preferably within the pharmaceutical industry required
Experience with production manufacturing; IT projects & management of IT systems required
Understanding of & knowledgeable in the following areas: IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11. System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems. Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories). Required
Expert in GxP documentation practices required
Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements required
Experience in project teams driving deliverables, tasks, & activities for computer system validation required
Preferred
Proficient in basic computer skills including experience with Microsoft Office preferred
Excellent oral & written communication skills preferred
Experience in regulatory audits & inspections preferred
Expert in utilizing appropriate root-cause analysis tools & techniques preferred
Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams preferred
Benefits
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
Company
Novo Nordisk
Novo Nordisk is a healthcare company that produces and distributes insulin and other diabetes drugs to treat chronic diseases.
10001+ employees
H1B Sponsorship
Novo Nordisk has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (25)
2024 (21)
2023 (13)
2022 (10)
2021 (9)
2020 (12)
Funding
Current Stage
Public CompanyTotal Funding
$22M2018-12-05Post Ipo Equity· $22M
1981-07-09IPO
Leadership Team
Lars Fruergaard Jørgensen
President and CEO
Lars Sorensen
President & CEO
Recent News
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