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.

Qualifications

• 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 required.
• Knowledge of pharmaceutical manufacturing business processes & how IT & automation integrate with them required.
• Excellent troubleshooting skills; ability identify root cause of a problem & assist in determining appropriate IT or technical solutions required.
• Demonstrated skills in identifying & leading medium to large scale IT validation projects required.
• Experience with developing & maintaining IT-focused policies, procedures & other documents required.
• Experience with HP Application Lifecycle Management software a plus.
• Project management & capital project experience strongly preferred.