IT Compliance Analyst - SDF

About the Department

For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. 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 Emerging Technologies
-Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

• 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.

Serve as IT's primary point of contact & subject matter expert (SME) on all IT related compliance policies & programs. Assist with the development & execution of key IT projects.

Reports to Manager.

• Improve our capability to provide quality to all IT & automation processes by analyzing & improving the levels of compliance (Project management, Quality programs)
• Ensure IT data systems are available, capable & accessible so that IT systems operate at the speed of business processes through quality initiatives & projects (ARE Management, business continuity & IT support)
• Recommend & implement quality initiatives to meet the customer’s needs, regulatory & internal compliance & add value to all business processes
• Become subject‑matter expert (SME) with NN validation software, eTIMs, within the IT team
• Project management – develop & utilize skills necessary to develop, manage & implement IT projects of all sizes (small to large scale projects)
• Manage change requests & system validation for IT
• Serve as IT lead for audits
• Coordinate with QA Compliance Specialists to assure compliance with procedures & policies
• Support & practice IT Security
• Follow all safety & environmental requirements in the performance of duties
• Comply with internal & external regulations & procedures
• Other duties as assigned

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.)

• Bachelor's Degree in Information Technology, Engineering or Automation from an accredited university is required. Master’s degree in a relevant field preferred
• Minimum of 5 years of IT experience, with some experience working in a pharmaceutical manufacturing environment required
• Experience with software development concepts required
• Proven experience with quality systems & proven problem solving skills required
• Excellent organizational skills & written/verbal communication skills required
• Knowledge of FDA regulations & guidelines as they relate to computer‑based information systems required
• In‑depth knowledge & training on compliance policies, programs & procedures as well as regulatory requirements, such as 21 CFR Part 11, electronic records retention, configuration items lists, revalidation, etc required
• Experience with quality procedures such as non‑conformities, change requests & IT system validation required
• Serve as the liaison between IT & Automation, internal & external QA organizations & other IT auditing organizations…