Sr IT Compliance Analyst

Location: Lexington, Massachusetts, or Clayton, North Carolina, United States; travel up to 10% may be required.

Company

Novo Nordisk operates pharmaceutical manufacturing facilities and develops treatments intended to improve the lives of people with chronic diseases.

What you will do

• Provide subject matter expertise in IT compliance, validation, qualification, process improvement, and service delivery management.
• Develop and maintain validation, qualification, system, and process documentation.
• Conduct risk assessments and impact analyses, identify compliance issues, and develop mitigation strategies.
• Guide project teams on validation and qualification requirements and facilitate project handovers to service operations.
• Participate as an IT subject matter expert in audits and inspections, providing documentation of validated system states.
• Collaborate with cross-functional teams, coach personnel, and support continuous improvement while meeting safety and environmental requirements.

Requirements

• Bachelor’s degree in IT, Engineering, Science, or a relevant field from an accredited university.
• At least seven years of IT compliance experience and five years of experience validating and testing IT solutions, preferably in the pharmaceutical industry.
• Excellent English writing and communication skills are required.
• Experience with regulatory compliance, documentation, audits, inspections, and IT solution lifecycle management.
• Strong skills in problem solving, negotiation, conflict management, planning, organization, decision-making, and handling complexity and ambiguity.
• Strong computer skills, including Microsoft Office Expert proficiency; ability to work in facility environments and lift or move equipment weighing up to 33 pounds.

Nice to have

• Master’s degree in IT, Engineering, Science, or a relevant field.
• Certified Information Systems Auditor (CISA) certification.
• Lean Six Sigma Green Belt or Black Belt certification.
• Experience with GxP, change management, deviation handling, and incident or problem management in IT.

Culture & Benefits

• Paid time off, including 14 paid holidays.
• Health, dental, and vision insurance effective from day one.
• Guaranteed 8% 401(k) contribution with an individual company match option.
• Paid parental and family medical leave, life and disability insurance, and tuition assistance.
• Mentorship, professional development resources, and employee referral awards.