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IT System Manager II

Facility:  Information Technology & Telecom
Location: 

Clayton, NC, US

About the Department   

At Novo Nordisk, we want to make a difference. For nearly 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. 
 
In Clayton, NC, we now operate two adjacent pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  
 
Our Clayton, NC Diabetes Finished Products (DFP) facility is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. When you work at DFP, you’ll join a global network of manufacturing professionals focused on several key, final production processes, including sterile formulation, filling, inspection, device assembly and packaging. 
 
At DFP, our employees are passionate about what they do, knowing their work makes a difference to millions of people who rely on our products every day. After all, producing medicines is a special responsibility. 
 
Join Team Novo Nordisk and help us make what matters.

 

Position Purpose

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.).

 

Accountabilities

  • 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 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
  • Documentation
    • System documentation including operational manuals, system architecture, & data flow completion
    • Works with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulations
    • Documentation of system configuration baselines
  • Security
    • Approves appropriate access to new users & removes access as necessary
    • Works with IT Security/SME to ensure controls are in place & 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 & external sources
  • System Projects: Performs activities assigned within agreed timelines
  • Other accountabilities, as assigned

 

Required Qualifications

  • BA/BS degree in Computer Science or Engineering, or similar applicable technical degree in relevant field
  • Minimum five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry
  • Experience with production manufacturing; IT projects & management of IT systems
  • Knowledgeable & have an understanding in the following areas
    • IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11
    • System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems
    • Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories)
  • Expert in GxP documentation practices
  • Proficient in basic computer skills including experience with Microsoft Office
  • Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements
  • Excellent oral & written communication skills
  • Experience in regulatory audits & inspections
  • Experience in project teams driving deliverables, tasks, & activities for computer system validation
  • Expert in utilizing appropriate root-cause analysis tools & techniques
  • Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams

 

Physical & Other Requirements

  • Occasionally moves equipment &/or supplies weighing up to 33 lbs. within the facility using various body positions
  • Constantly operates a computer & other office equipment using hands
  • Ability to work in an open office environment with the possibility of frequent distraction
  • Ability to work hours necessary to support a 24/7 continuous manufacturing operation
  • Novo Nordisk requires all employees to be fully vaccinated with a COVID-19 vaccine by December 8, 2021.  As required by applicable law, Novo Nordisk will consider requests for reasonable accommodation for those unable to be vaccinated. You will be required to upload an image of your COVID-19 vaccine card at the time of hire and/or on your first day of employment.

 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

 

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.