Senior IT Systems Manager – Validation & Lifecycle

Biopharma Careers; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid parental leave

Family medical leave

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Job summary

Novo Nordisk in Petersburg, Virginia, seeks an IT Systems Governance professional to manage governance, project oversight, and schedule adherence for IT systems. You will oversee the full system lifecycle, from development to retirement, ensuring regulatory compliance and robust incident management.

Responsibilities include system security, validation approaches, documentation, and user training, with collaboration across SMEs and IT teams. Travel up to 10% may be required.

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

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

Education

Bachelor's Degree in computer science, engineering or related field

Associate's Degree in computer science, engineering or related field

High School Diploma or equivalent

Experience supporting and troubleshooting automation/IT systems & batch processes

System development & lifecycle management including validation

Troubleshooting IT system issues (interfaces & hardware)

GxP documentation practices

Excellent oral & written communication skills

Regulatory audits & inspections experience

IT validation project experience

COBIT/ITIL/GAMP/21CFR Part 11/PIC/S Annex 11 familiarity

API processes & batch sequencing knowledge

Statistical thinking for problem solving

Cross-functional project teamwork

Job description

Novo Nordisk in Petersburg, Virginia, seeks an IT Systems Governance professional to manage governance, project oversight, and schedule adherence for IT systems. You will oversee the full system lifecycle, from development to retirement, ensuring regulatory compliance and robust incident management.

Responsibilities include system security, validation approaches, documentation, and user training, with collaboration across SMEs and IT teams. Travel up to 10% may be required.