Senior IT Systems Manager: Validation & Compliance

Novo Nordisk; Petersburg (VA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Leading pay and annual performanceBONu

14 paid holidays

Health, Dental, Vision insurance from

8% 401K company match

14 weeks parental leave

Life & Disability Insurance

Tuition Assistance

Employee Referral Awards

Free access to Novo Nordisk products

Job summary

Novo Nordisk is seeking a skilled IT Systems Governance professional for our Petersburg, VA site. You will oversee governance, lifecycle management, and regulatory compliance for enterprise IT systems within a pharmaceutical-like environment.

Responsibilities include ensuring security controls, validation testing, and collaboration with SMEs to maintain compliant, efficient systems across the organization.

Qualifications

• Bachelor's degree in computer science, engineering or related field and seven+ years in operation & maintenance of IT systems
• Experience supporting and troubleshooting automation/IT systems & batch processes
• Experience in system development, lifecycle management and validation of computer systems
• Proficient at troubleshooting IT system issues and interfaces
• Expert in GxP documentation practices
• Excellent oral and written communication skills
• Experience in regulatory audits & inspections
• Knowledge of IT frameworks (COBIT, ITIL, GAMP, 21CFR Part 11, PIC/S Annex 11)
• Functional knowledge of API processes & batch sequencing preferred

Responsibilities

• Manages IT system governance and oversees the full system lifecycle (development, maintenance, operation, retirement)
• Ensures system security controls and documentation
• Oversees validation approaches and testing (IQ/OQ/PQ, FAT/SAT/UAT)
• Manages system change control with risk-based approach
• Maintains configuration baselines and system documentation
• Ensures user training and support are in place
• Reviews testing protocols and approves results
• Supports audits and inspections
• Manages project portfolio for software upgrades and hardware lifecycle
• Ensures compliance with regulatory requirements and safety standards
• Acts as primary escalation point for system support and improvements
• Liaises with SME to implement corrective actions and prevent incidents

Skills

IT governance

Validation testing

Regulatory audits

GxP

IT security

SOP compliance

Data integrity

Education

Bachelor’s Degree in computer science/engineering or related field

Job description

Novo Nordisk is seeking a skilled IT Systems Governance professional for our Petersburg, VA site. You will oversee governance, lifecycle management, and regulatory compliance for enterprise IT systems within a pharmaceutical-like environment.

Responsibilities include ensuring security controls, validation testing, and collaboration with SMEs to maintain compliant, efficient systems across the organization.