Senior IT System Manager at Novo Nordisk

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 12 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 Positions

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

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).

 

Qualifications

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

 

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.