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 life-changing careers, and 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 12 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 Manage the governance, provide project oversite, drive the schedule & ensure adherence to the documented requirements for system management of assigned IT Systems. This includes the full system lifecycle management process (system development, system maintenance & operation, compliance with regulatory & Novo Nordisk requirements, incident & change management & retirement of systems). Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, Financial, Personal Data Protection, etc.). Relationships Reports to Manager, Automation System Mgmt API. Essential Functions + Manages the IT system requirements by ensuring system compliance with relevant SOPs & guidelines, as well as external requirements (system security, audit trail, data integrity/retention/archival/restoration, patching, system monitoring, system continuity & contingency plan, etc.) + Works with IT Security/SME to ensure appropriate system security controls are in place & documented + Ensures appropriate validation approach & qualification testing is in place to ensure IT requirements are met (i.e. FAT, SAT, UAT, IQ, OQ, PQ and/or GEP) + Manages the system lifecycle process & provides strategic perspective for the IT roadmap + Manages system change control with a risk-based approach + Reviews & approves testing protocols to ensure requirements are tested appropriately + Manages the system configuration & supports determining the configurable items that are documented in the configuration baseline standards + Manages the system documentation (operation & maintenance standards, specifications, configuration baselines, instructional manuals, system architecture, data flows, system assessments, etc.) + Works closely with Subject Matter Expert (SME) to ensure system documentation complies with local, corporate & regulatory regulations + Ensures user training & user support are in place + Manages the approval of access for new users & performs user access reviews to determine access removal + Ensures continued & improved overall user satisfaction with system + Works with cross-functional project teams for process improvement + Works closely with SME to understand & determine solutions for IT incidents & deviations, to ensure effective corrective actions are identified & implemented to prevent incident recurrence + Supports establishing support standards & processes (internal & external support contracts/service level agreements (SLA), licensing contracts, incident handling, etc.) + Serves as primary escalation point for system support, improvements & projects + Ensures that the validated state is maintained & monitored according to the established requirements by managing the Periodic System Evaluations (PSE) & reviewing system data to ensure IT controls are actively functioning as designed to ensure compliance with the documented system requirements + Evaluates system alarms, user access, deviations & trends + Supports audits & inspections + Manages the project portfolio for the system (software upgrades, managing hardware obsolescence, retirement, etc.) + Maintains a safe work environment + Other accountabilities, 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 computer science/engineering/related field, equivalent combination of experience & education, or 5 years pharmaceutical IT system management experience focusing on compliance preferred + Minimum of five (5) years of engineering experience operation & maintenance of IT systems preferred + Minimum of five (5) years of pharmaceutical industry experience (GxP) preferred + Minimum of five (5) years of supporting & troubleshooting automation/IT systems & batch processes a plus + Proficient at troubleshooting (systematic problem solving) automated/IT system issues, including interfaces & hardware components preferred + Understanding of IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 a plus + Functional knowledge of API processes & batch sequencing a plus + Expert in system development & lifecycle management including validation of computer systems, operation & maintenance & retirement preferred + Functional understanding of the application of statistical analysis to problem solving preferred + Expert in GxP documentation practices required + Excellent oral & written communication skills required + Experience in regulatory audits & inspections required + Expert in planning/organizing critical path milestones & resource demands, developing detailed schedules, managing task execution, process confirming results, adapting to the agility of a production environment, working with cross functional teams & revising the work plan for unplanned complex problems required. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing. 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.