IT System Manager II

What we offer you: 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 leave and 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 systems throughout their lifecycle, provide project oversight and drive deliverables, partner with key stakeholders, and ensure adherence to Novo Nordisk and regulatory requirements for assigned IT systems. Ensure processes are in place for system maintenance and operation according to relevant regulatory authorities (GxP, financial, personal data protection, etc.). Essential Functions Ensures system compliance with relevant internal SOPs and guidelines as well as external requirements (21 CFR Part 11, personal data protection, Sarbanes–Oxley, etc.). Reviews and maintains all IT CSV validation and system decommissioning documentation in accordance with regulatory and Novo Nordisk requirements. Responsible for the system life‑cycle management and suggests inputs for the IT roadmap. Documents operation and maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity and recovery plans). Performs system reviews to ensure basic IT controls are in place and in control to ensure compliance and security of the system. Acts as a peer mentor providing reviews and input to documentation prepared by other team members. Ensures appropriate testing (FAT, SAT, UAT, IQ, OQ, PQ, and/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 and implemented. Represents IT systems in connection with audits and inspections. Documentation System documentation including operational manuals, system architecture, and data flow completion. Works with subject‑matter experts to ensure system documentation is compliant with local, corporate, and regulatory regulations. Documentation of system configuration baselines. Security Approves appropriate access to new users and removes access as necessary. Works with IT security and subject‑matter experts to ensure controls are in place and documented. Performs annual system evaluation. System Support Serves as the escalation point for system support. Ensures end‑user training is in place, as required. Prepares support agreements with internal and external sources. System Projects Performs activities assigned within agreed timelines. Other accountabilities, as assigned. Physical Requirements Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (percentage may change on a case‑by‑case basis based on the role). Qualifications Bachelor's degree in computer science or engineering, or a similar applicable technical degree in a relevant field required. Minimum five years of operation and maintenance of IT systems, preferably within the pharmaceutical industry required. Experience with production manufacturing; IT projects and management of IT systems required. Knowledgeable and have an understanding in the following areas: IT frameworks such as COBIT, ITIL, GAMP, 21 CFR Part 11, and/or PIC/S Annex 11 required. System development lifecycle including validation of computer systems, operation and maintenance, and decommissioning of systems required. Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, and laboratories) required. Expert in GxP documentation practices required. Proficient in basic computer skills, including experience with Microsoft Office required. Ability to independently review and approve protocols and technical documents in compliance with regulatory and Novo Nordisk requirements required. Excellent oral and written communication skills required. Experience in regulatory audits and inspections required. Experience in project teams driving deliverables, tasks, and activities for computer system validation required. Expert in utilizing appropriate root‑cause analysis tools and techniques required. Demonstrated expertise in planning, organizing, managing execution, checking results, and revising the work plan for complex problems being resolved by cross‑functional teams required. ~Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state, federal laws, rules or regulations. #J-18808-Ljbffr Initial Therapeutics, Inc.