Sr IT Compliance Analyst (Clayton, NC, US)

NCBiotech; Clayton (NC); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K matching

Paid time off + holidays

Job summary

Novo Nordisk in Clayton, NC seeks an IT Compliance expert to provide subject matter expertise in IT compliance, process improvement, and service delivery management across the site. You will ensure IT solutions meet regulatory standards and drive governance, data integrity, and patient safety.

The role focuses on guiding validation, risk assessment, and handover to operations, with opportunities to influence lifecycle management and cross-functional collaboration in a leading pharmaceutical

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 deal with complexity and ambiguity required
• Strong computer skills and MS Office Expert required

Responsibilities

• 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

Skills

Communication skills

English proficiency

Team collaboration

Problem solving

Decision making

Interpersonal skills

Education

Bachelor's degree in IT/Engineering/Science

Master's degree in IT/Engineering/Science

Tools

MS Office

Job description

About the Department

At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square-feet of state-of-the-­art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk’s innovative oral products. At API, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Provide subject matter expertise in IT compliance, process improvement and IT compliance service delivery management across the site. Ensures that IT solutions are compliant with relevant regulations and standards and facilitates the seamless transition and handover of projects to service operations with key stakeholders. Ensures governance and continuous improvement as an enabler supporting product quality, patient safety, and data integrity and contributes to the organization’s goals of improving the lives of people with chronic diseases.

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 &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12 hour shift. May require corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections. Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. % can 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 deal with complexity and ambiguity required
• Strong computer skills and MS Office Expert required

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

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.