IT System Manager III - API manufacturing

Novo Nordisk • Petersburg, VA

2d • Onsite

About The Position

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.).

Requirements

• Bachelor's Degree in computer science, engineering or related field from an accredited university and a minimum of seven (7) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• In lieu of Bachelor’s Degree and seven (7) years of experience, may consider an Associate’s Degree in computer science, engineering or related field from an accredited college or university and a minimum of nine (9) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• In lieu of Bachelor’s Degree and seven (7) years of experience, may consider a High School Diploma or equivalent and a minimum of eleven (11) years of experience in operation & maintenance of IT systems required, preferably within the pharmaceutical industry
• Experience supporting and troubleshooting automation/IT systems & batch processes required
• Experience in system development & lifecycle management including validation of computer systems, operation & maintenance, & decommissioning of systems required
• Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components required
• Expert in GxP documentation practices required
• Excellent oral & written communication skills required
• Experience in regulatory audits & inspections required
• Experience in project teams driving deliverables, tasks, & activities for computer system validation required

Nice To Haves

• Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, and/or PIC/S Annex 11 preferred
• Functional knowledge of API processes & batch sequencing preferred
• Functional understanding of the application of statistical analysis to problem solving 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

• 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

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: Senior