Lead IT Compliance & Validation—IT & OT Expert

Initial Therapeutics, Inc.; Virginia (MN); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

8% 401K contribution

Paid time off & holidays

Parental & family leave

Job summary

Novo Nordisk is seeking an IT Compliance senior specialist at our Petersburg, VA site to lead validation, qualification, and governance for IT systems supporting product quality, patient safety, and data integrity.

You will partner with cross‑functional teams, drive risk assessments, and ensure compliant project handovers to operations, while mentoring staff and contributing to continuous improvement initiatives.

Qualifications

• Bachelor’s degree in IT, Engineering, Science or related field with 7+ years IT compliance and 5+ years validation/testing.
• Master’s degree preferred with 5+ years IT compliance and 3+ years validation/testing; pharma experience preferred.
• Excellent English communication.
• Strong collaboration and customer service.
• Ability to manage complexity and ambiguity.
• Proficient with MS Office.

Responsibilities

• Develop and maintain validation and qualification documentation.
• Conduct risk assessments and impact analyses for compliance.
• Provide guidance and support to project teams on validation and qualification requirements.
• Continuously monitor and improve documentation to ensure regulatory compliance.
• Facilitate seamless transition of projects to service operations with stakeholders.
• Maintain system documentation and processes per regulatory standards.
• Participate as IT SME in audits and inspections with proper documentation.
• Collaborate with cross-functional teams to meet business needs, on time and within budget.
• Ensure IT solutions, documentation and processes follow regulatory requirements.
• Provide leadership in IT compliance, process improvement, and project coordination.
• Coach and mentor personnel; participate in process group activities.
• Follow all safety & environmental requirements.
• Other duties as assigned.

Skills

IT compliance

Validation & Testing

English proficiency

Team collaboration

Problem solving

Planning & organization

MS Office proficiency

Education

Bachelor's degree in IT/Engineering/Science

Master's degree in IT/Engineering/Science

Job description

Novo Nordisk is seeking an IT Compliance senior specialist at our Petersburg, VA site to lead validation, qualification, and governance for IT systems supporting product quality, patient safety, and data integrity.

You will partner with cross‑functional teams, drive risk assessments, and ensure compliant project handovers to operations, while mentoring staff and contributing to continuous improvement initiatives.