IT System Manager II
Company: Novo Nordisk
Location: Clayton
Posted on: February 24, 2026
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Job Description:
About the Department You will be joining Fill & Finish
Expansions (FFEx), which is responsible for all major expansion
activities within aseptic production, solid dosage forms, finished
products, fill & finish warehousing, and QC across all production
areas in Product Supply. The area is anchored in Product Supply,
Quality & IT, which globally employ approx. 20,000 of Novo
Nordisk’s 50,000 employees. FFEx is a newly established and growing
area with the responsibility to design, plan, and build all new
aseptic filling capacity across Novo Nordisk to serve the needs of
millions of patients. We do it by rethinking our production
facilities with the use of modern technology, as we are setting the
standards for the aseptic production of the future. Facilities
designed today which we will still be proud of 20 years from now.
FF Expansions has a global approach, where you will be working with
multiple sites and cultures across the world. 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 & 6 weeks paid family medical leave • Free access to Novo
Nordisk-marketed pharmaceutical products • Tuition Assistance •
Life & Disability Insurance • Employee 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 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
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.
(% 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.
Keywords: Novo Nordisk, Burlington , IT System Manager II, IT / Software / Systems , Clayton, North Carolina
