Sr IT Compliance Analyst

Novo Nordisk; Clayton (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Generous paid time off

Health, Dental, and Vision Insurance

401K contribution

Tuition Assistance

Job summary

Novo Nordisk in Clayton, NC is looking for an experienced professional to provide IT compliance and process improvement expertise. The role involves ensuring regulatory compliance, documentation maintenance, and collaboration with project teams. Candidates should have a Bachelor’s Degree in IT, Engineering, or Science and at least 7 years of IT compliance experience, preferably in the pharmaceutical sector.

Additional skills in Lean Six Sigma and strong communication abilities are essential for this position. The company values inclusivity and offers comprehensive health benefits and paid time off.

Qualifications

• Minimum of 7 years of experience in IT compliance.
• 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.
• Ensure compliance with regulatory requirements.

Skills

IT compliance

Process improvement

Validation and Testing of IT Solutions

Communication skills

Problem-solving

Education

Bachelor’s Degree in IT, Engineering, Science, or relevant field

Master’s degree in IT, Engineering, Science, or relevant field (preferred)

Tools

MS Office

Lean Six Sigma

Job description

About the Department

At Novo Nordisk, we help improve the quality of life for millions of people worldwide. For over 100 years, we have led the way in diabetes care. In North Carolina we operate three pharmaceutical manufacturing facilities, including an active pharmaceutical ingredients (API) site in Clayton, NC.

What We Offer You

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

The Position

Provide subject‑matter expertise in IT compliance, process improvement, and IT compliance service delivery management at the site. Ensure compliance with regulations and standards and support the seamless transition of projects to service operations.

Relationships

Reports to Director / Associate Director.

Essential Functions

• Develop and maintain validation and qualification documentation
• Conduct risk assessments and impact analyses to identify potential compliance issues and develop mitigation strategies
• Provide guidance and support to project teams on validation and qualification requirements
• Continuously monitor and improve documentation and processes to ensure compliance with regulatory requirements and Novo Nordisk standards
• Facilitate the seamless transition and handover of projects to service operations with key stakeholders
• Maintain system documentation and process according to Novo Nordisk standards and in compliance with regulatory requirements
• Participate as an IT SME in audits and inspections and provide needed documentation to demonstrate validated state and proper management of IT solutions throughout the life cycle
• Collaborate with cross‑functional teams to ensure that all IT solutions meet business needs, are delivered on time & within budget, are properly documented, and managed throughout their life cycle
• Ensure that all IT solutions, documentation, and processes are following regulatory requirements and Novo Nordisk standards
• Provide leadership and expertise in IT compliance, process improvement, and project coordination
• Coach and mentor personnel, and provide guidance as needed
• Participate in process group meetings and contribute to process group activities
• Follow all safety & environmental requirements in the performance of duties
• Other duties as assigned

Physical Requirements

May move equipment & supplies weighing up to 33 pounds, stand up to a 12‑hour shift, require corrected vision of 20/20 or 20/25, color vision, work in loud noise environments with hearing protection, work in an open office with frequent distraction, and travel up to 10% of the time. These percentage requirements may change on a case‑by‑case basis based on the role.

Qualifications

• Bachelor’s Degree in IT, Engineering, Science, or relevant field of study from an accredited university required
• Master’s degree in IT, Engineering, Science, or relevant field of study from an accredited university 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) is preferred
• Lean Six Sigma Green Belt or Black Belt is preferred
• Experience as SME participating in Audits and Inspections preferred
• Experience on GxP, change management and deviation handling preferred
• Experience with Incident, Problem, and Change Management in IT preferred
• Excellent writing and communication skills, in English required
• Excellent customer service skills and ability to collaborate effectively in a team environment required
• Excellent problem solving, negotiation, conflict management, and interpersonal skills required
• Excellent planning, organizing, decision making and ability to deal with complexity and ambiguity required
• Strong computer skills and MS Office Expert required

Equal Opportunity and Inclusion

We commit to an inclusive recruitment process and equality of opportunity for all job applicants. Novo Nordisk is an equal‑opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status, or any other characteristic protected by local, state or federal laws, rules, or regulations.

For special assistance or accommodation to apply, call 1‑855‑411‑5290. This contact is for accommodation requests only.