IT System Manager II
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Clayton • North Carolina • United States
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Tech Stack
About the role
- Manage systems throughout their lifecycle, provide project oversite and drive deliverables, partner with key stakeholders, & ensure adherence to the Novo Nordisk and regulatory requirements for assigned IT Systems.
- Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, financial, personal data protection, etc.)
- 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 providing reviews and input to documentation prepared by other team members
- Ensures appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are met
- Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
- Represents IT systems in connection with audits and inspections
- Works with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulations
- Approves appropriate access to new users & removes access as necessary
- Serves as the escalation point for system support
- Ensures end user training is in place, as required
- Prepares support agreements with internal & external sources
- Performs activities assigned within agreed timelines
Requirements
- Bachelor's Degree in Computer Science or Engineering, or similar applicable technical degree in relevant field required
- Minimum five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry required
- Experience with production manufacturing; IT projects & management of IT systems required
- Knowledgeable & have an understanding in the following areas: required IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 required
- System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems required
- Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories). Required
- Expert in GxP documentation practices required
- Proficient in basic computer skills including experience with Microsoft Office required
- Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements required
- Excellent oral & written communication skills required
- Experience in regulatory audits & inspections required
- Experience in project teams driving deliverables, tasks, & activities for computer system validation required
- Expert in utilizing appropriate root-cause analysis tools & techniques required
- Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams required
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
IT system lifecycle managementsystem validationGxP documentation practicesCOBITITILGAMP21CFR Part 11root cause analysisdata integrityincident management
Soft Skills
communication skillsproject managementmentoringproblem solvingplanningorganizationcollaborationindependent reviewtask managementtraining
Certifications
Bachelor's Degree in Computer ScienceBachelor's Degree in Engineering