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 and obesity. Being part of Novo Nordisk allows our employees to help improve the quality of life for millions of people around the world. What We Offer You Leading pay and an annual performance bonus for all positions. All employees enjoy generous paid time off, including 14 paid holidays. Health, dental and vision insurance are effective on day one. We offer a guaranteed 8% 401(k) contribution plus a company match option. Family‑focused benefits include 14 weeks paid parental leave and six weeks paid family medical leave. Additional benefits include free access to Novo Nordisk‑marketed pharmaceutical products, tuition assistance, life and disability insurance, and employee referral awards. The Position Serve as IT’s primary point of contact and subject‑matter expert (SME) on all IT‑related compliance policies and programs. Assist with the development and execution of key IT projects. Relationships Reports to Manager. Essential Functions Improve the capability to provide quality to all IT and automation processes by analyzing and improving compliance levels (project management, quality programs). Ensure IT data systems are available, capable, and accessible so that IT systems operate at the speed of business processes through quality initiatives and projects (ARE management, business continuity & IT support). Recommend and implement quality initiatives to meet customer needs, regulatory and internal compliance, and add value to all business processes. Become SME with Novo Nordisk validation software, eTIMs, within the IT team. Project manage—develop and utilize skills necessary to develop, manage, and implement IT projects of all sizes. Follow all safety and environmental requirements in the performance of duties. Manage change requests and system validation for IT. Serve as IT lead for audits. Coordinate with QA Compliance Specialists to assure compliance with procedures and policies. Support and practice IT security. Comply with internal and external regulations and procedures. 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 (percentages may change on a case‑by‑case basis). 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 five years of IT experience, with some experience working in a pharmaceutical manufacturing environment. Experience with software development concepts. Proven experience with quality systems and problem‑solving skills. Excellent organizational, written, and verbal communication skills. Knowledge of FDA regulations and guidelines as they relate to computer‑based information systems. In‑depth knowledge and training on compliance policies, programs and procedures such as 21 CFR Part 11, electronic records retention, configuration item lists, revalidation, etc. Experience with quality procedures such as non‑conformities, change requests, and IT system validation. Liaison between IT & Automation, internal & external QA organizations and other IT auditing organizations. Knowledge of pharmaceutical manufacturing business processes and how IT & automation integrate with them. Excellent troubleshooting skills; ability to identify root cause of a problem and assist in determining appropriate technical solutions. Demonstrated skill in identifying and leading medium to large‑scale IT validation projects. Possesses a broad range of expertise in principles, methods, practices, standards, procedures and compliance requirements relevant to designing and developing complex IT solutions. Provides solutions aligned with site strategies and compliant with company architectural and operating standards. Experience with developing and maintaining IT‑focused policies, procedures, and documents. Experience with HP Application Lifecycle Management software is a plus. Project management and capital project experience strongly preferred. Equal Opportunity & Accommodations We commit to an inclusive recruitment process and equality of opportunity for all 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. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call View phone number on click.appcast.io. This contact is for accommodation requests only and cannot be used to inquire about the status of applications. #J-18808-Ljbffr BioSpace, Inc.