Job Description
IT Compliance Analyst - SDF Novo Nordisk - 4.1 Durham, NC Job Details 1 hour ago Benefits 401(k) 8% Match Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Paid time off Parental leave Vision insurance 401(k) matching Qualifications Software engineering Application systems Automation IT quality control IT policy development IT auditing
FDA 21 CFR
Part 11 Manufacturing facility Technical solutions implementation Policy & process development Pharmaceutical company experience Interdisciplinary policy and procedure development Root cause analysis Regulatory compliance analysis Implementing IT solutions Policy Development Non-conformance reporting Pharmaceutical manufacturing facility experience Full Job Description IT Compliance Analyst - SDF Facility:
Digital & IT Location:
Durham, NC, US 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. 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 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. Relationships Reports to Manager. Essential Functions 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) Follow all safety & environmental requirements in the performance of duties 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 Follow all safety and environmental requirements in the performance of duties Other duties as assigned Physical Requirements 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 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 Possesses & applies a broad range of expertise of principles, methods, practices, standards, procedures & compliance requirements of a particular business function in designing & developing complex IT solutions required Provides solutions which are aligned with site strategies & comply with the company's architectural & operating standards & requirements 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 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. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
