IT System Manager II

IT System Manager II Employer Novo Nordisk Location Clayton, NC Start date May 23, 2026 View more categories View less categories Discipline Engineering , Information Technology , Applications/Technical Support , Software Development , System Administration Required Education Associate Degree Position Type Full time Hotbed Bio NC , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details About the Department At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do.

What we offer you:

Leading pay and annual performance bonus for all positionsAll employees enjoy generous paid time off including 14 paid holidays Health Insurance, Dental Insurance, Vision Insurance - effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition Assistance Life & Disability InsuranceEmployee Referral Awards At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters. The Position 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.). Relationships Reports to Supervisor, IT System Management & Validation.

Essential Functions Systems Management:

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 requirementsResponsible for the system life cycle management & suggests inputs for the IT roadmapDocuments 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 systemActs as a peer mentor providing reviews and input to documentation prepared by other team membersEnsures appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are metParticipates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implementedRepresents IT systems in connection with audits and inspections

Documentation:

System documentation including operational manuals, system architecture, & data flow completionWorks with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulationsDocumentation of system configuration baselines

Security:

Approves appropriate access to new users & removes access as necessaryWorks with IT Security/SME to ensure controls are in place & documentedPerforms annual system evaluation

System Support:

Serves as the escalation point for system supportEnsures end user training is in place, as requiredPrepares support agreements with internal & external sources

System Projects:

Performs activities assigned within agreed timelinesOther 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. (% can change on a case-by-case basis based on the role.) Qualifications Bachelor's Degree in Computer Science or Engineering, or similar applicable technical degree in relevant field requiredMinimum five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry requiredExperience with production manufacturing; IT projects & management of IT systems requiredKnowledgeable & have an understanding in the following areas: requiredIT frameworks such as

COBIT, ITIL, GAMP, 21CFR

Part 11, &/or PIC/S Annex 11 requiredSystem development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems requiredManufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories). Required Expert in GxP documentation practices requiredProficient in basic computer skills including experience with Microsoft Office requiredAbility to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements requiredExcellent oral & written communication skills requiredExperience in regulatory audits & inspections requiredExperience in project teams driving deliverables, tasks, & activities for computer system validation requiredExpert in utilizing appropriate root-cause analysis tools & techniques requiredDemonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams required We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk, we're not chasing quick fixes - we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger - a legacy of impact that reaches far beyond today. 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 or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. Company Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com . Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R D, from early research through late-stage clinical development. We are building for the future by creating a distinct R D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

CONNECT Company info Website https:

//www.novonordisk-us.com/ Phone 617-612-6200 Location 75 Hayden Avenue Lexington

MA 02421

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