IT System Manager III - API manufacturing

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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.

Our new Petersburg, Virginia site marks a strategic move to advance our capabilities in Emerging Technologies (ET) within Chemical API development and production. The highly experienced site is designed to strengthen and accelerate our Small Molecule (SMOL) strategy while amplifying our operational capacity. This is to safeguard and support ET´s SMOL projects in the coming years, aligning with our vision and strengthening our potential for growth and innovation.

• 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 14weeks 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.

Manage the governance, provide project oversite, drive the schedule & ensure adherence to the documented requirements for system management of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory & Novo Nordisk requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Personal Data Protection, etc.).

Reports to Senior Manager.

• Manages the IT system requirements by ensuring system compliance with relevant SOPs and guidelines, as well as external requirements (system security, audit trail, data integrity/retention/archival/restoration, patching, system monitoring, system continuity & contingency plan, etc.)
• Works with IT Security/SME to ensure appropriate system security controls are in place & documented
• Ensures appropriate validation approach & qualification testing is in place to ensure IT requirements are met (i.e. FAT, SAT, UAT, IQ, OQ, PQ, and/or GEP)
• Manages the system lifecycle process & provides strategic perspective for the IT roadmap
• Manages system change control with a risk-based approach
• Reviews & approves testing protocols to ensure requirements are tested appropriately
• Manages the system configuration & supports determining the configurable items that are documented in the configuration baseline standards
• Manages the system documentation (operation & maintenance standards, specifications, configuration baselines, instructional manuals, system architecture, data flows, system assessments, etc.)
• Works closely with Subject Matter Expert (SME) to ensure system documentation complies with local, corporate & regulatory regulations
• Ensures user training & user support are in place
• Manages the approval of access for new users & performs user access reviews to determine access removal
• Ensures continued & improved overall user satisfaction with system
• Occasionally, leads cross-functional project teams for process improvement
• Works closely with SME to understand & determine solutions for IT incidents & deviations, to ensure effective corrective actions are identified & implemented to prevent incident recurrence
• Establishes support standards & processes (internal & external support contracts/service level agreements (SLA), licensing contracts, incident handling, etc.)
• Serves as primary escalation point for system support, improvements & projects
• Ensures that the validated state is maintained & monitored according to the established requirements by managing the Periodic System Evaluations (PSE) & reviewing system data to ensure IT controls are actively functioning as designed to ensure compliance with the documented system requirements
• Evaluates system alarms, user access, deviations & trends
• Supports audits & inspection.
• Manages the project portfolio for the system (software upgrades, managing hardware obsolescence, retirement, etc.).
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

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.)

• Bachelor's Degree in computer science, engineering or related field from an accredited university and a minimum of…