IT System Manager II

Role Overview

• 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

Tech Stack

• Assembly

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