The PositionManage 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.).
RelationshipsReports to Senior Manager.
Essential Functions- 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
Physical RequirementsAbility 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, 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
- 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
