Strategic IT Compliance & Validation Lead

BioSpace; Clayton (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K company match

Job summary

Novo Nordisk is seeking an experienced IT compliance professional to provide subject matter expertise in compliance, process improvement, and service delivery across our Clayton, NC site. You will ensure IT solutions meet regulatory standards, enable smooth project handovers to operations, and support product quality, patient safety, and data integrity.

The role requires leading governance, documenting validation activities, and participating in audits/inspections.

Qualifications

• Minimum of seven (7) years of experience in IT compliance.
• Minimum of five (5) years of experience on Validation and Testing of IT Solutions.
• Excellent writing and communication skills in English.

Responsibilities

• Develop and maintain validation and qualification documentation.
• Conduct risk assessments and impact analyses to identify potential compliance issues and mitigation strategies.
• Provide guidance to project teams on validation/qualification requirements.
• Monitor and improve documentation to ensure regulatory compliance and Novo Nordisk standards.
• Facilitate transition of projects to service operations with stakeholders.
• Maintain system documentation per Novo Nordisk standards and regulatory requirements.
• Participate in audits and inspections as IT SME and provide required documentation.

Skills

IT compliance

Validation & testing

Audits & inspections

GxP knowledge

Change management

English communication

MS Office expert

Education

Bachelor's degree in IT/Engineering/Science

Master’s degree preferred

Tools

CISA (preferred)

Lean Six Sigma Green/Black Belt (preferred)

Job description

Novo Nordisk is seeking an experienced IT compliance professional to provide subject matter expertise in compliance, process improvement, and service delivery across our Clayton, NC site. You will ensure IT solutions meet regulatory standards, enable smooth project handovers to operations, and support product quality, patient safety, and data integrity.

The role requires leading governance, documenting validation activities, and participating in audits/inspections.