IT System Manager III - Multiple Openings

Novo Nordisk • Clayton, NC

2d

About The Position

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 & drive deliverables, partner with key stakeholders, & ensure adherence to the Novo Nordisk & 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.). Acts as a team lead in assigned areas of responsibility. 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 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 & lead in reviewing documentation prepared by team members Review & approves testing protocols to ensure requirements are tested appropriately Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented Audit & inspection support Documentation: System documentation including operational manuals, system architecture, & data flow completion Works with subject matter expert (SME) to ensure system documentation is in compliance 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: Ability to lead projects & project teams as needed. 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.)

Requirements

• Bachelor's Degree in Computer Science or Engineering, or similar applicable technical degree in relevant field required
• Minimum seven (7) years of operation & maintenance of IT systems preferably within the pharmaceutical industry required
• Experience with production manufacturing; IT projects & management of IT systems required
• Understanding of & knowledgeable 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).
• Required Expert in GxP documentation practices required
• Proficient in basic computer skills including experience with Microsoft Office preferred
• Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements required
• Excellent oral & written communication skills preferred
• Experience in regulatory audits & inspections preferred
• Experience in project teams driving deliverables, tasks, & activities for computer system validation required
• Expert in utilizing appropriate root-cause analysis tools & techniques preferred
• Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams preferred

Responsibilities

• 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 & lead in reviewing documentation prepared by team members
• Review & approves testing protocols to ensure requirements are tested appropriately
• Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
• Audit & inspection support
• System documentation including operational manuals, system architecture, & data flow completion
• Works with subject matter expert (SME) to ensure system documentation is in compliance with local, corporate & regulatory regulations
• Documentation of system configuration baselines
• 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
• Serves as the escalation point for system support
• Ensures end user training is in place, as required
• Prepares support agreements with internal & external sources
• Ability to lead projects & project teams as needed.
• Performs activities assigned within agreed timelines
• Other accountabilities, as assigned

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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level