IT Compliance Analyst - Validation & Audit

Biopharma Careers; Iowa (LA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid time off & holidays

Tuition Assistance

Life & Disability Insurance

Employee Referrals

Job summary

Novo Nordisk seeks an IT compliance specialist to provide subject matter expertise across site IT compliance, validation, and service delivery. You will ensure regulatory alignment and seamless project handovers to operations while supporting product quality and data integrity.

The role emphasizes governance, continuous improvement, and collaboration with cross-functional teams to meet timelines and budgets in a life-sciences environment.

Qualifications

• Bachelor’s Degree in IT, Engineering, Science, or relevant field required.
• Master’s degree in IT, Engineering, Science, or relevant field preferred.
• Minimum of seven (7) years of experience in IT compliance required, preferably within the pharmaceutical industry.
• Minimum of five (5) years of experience on Validation and Testing of IT Solutions required, preferably within the pharmaceutical industry.
• Certified Information Systems Auditor (CISA) preferred, Lean Six Sigma Green/Black Belt preferred.
• Experience with GxP, change management and deviation handling preferred.
• Excellent writing and communication skills in English required.

Responsibilities

• Develop and maintain validation and qualification documentation.
• Conduct risk assessments and impact analyses to identify compliance issues and mitigation strategies.
• Provide guidance on validation and qualification requirements to project teams.
• Monitor and improve documentation to ensure regulatory compliance and Novo Nordisk standards.
• Facilitate transition of projects to service operations with stakeholders.
• Maintain system documentation and processes per company standards and regulatory requirements.
• Participate as IT SME in audits and inspections and provide necessary documentation.
• Collaborate with cross-functional teams to ensure IT solutions meet business needs and budgets.

Skills

English proficiency

Communication

Team collaboration

Problem solving

Decision making

Education

Bachelor’s Degree in IT/Engineering/Science

Master’s degree preferred

Tools

CISA

Lean Six Sigma Green Belt/Black Belt

MS Office Expert

Job description

Novo Nordisk seeks an IT compliance specialist to provide subject matter expertise across site IT compliance, validation, and service delivery. You will ensure regulatory alignment and seamless project handovers to operations while supporting product quality and data integrity.

The role emphasizes governance, continuous improvement, and collaboration with cross-functional teams to meet timelines and budgets in a life-sciences environment.