About the Department
At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. 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 Product Supply Aseptic Manufacturing (PS AM) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At PS AM, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
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 systems throughout their lifecycle, provide project oversite and drive deliverables, partner with key stakeholders, & ensure adherence to the Novo Nordisk and regulatory requirements for assigned IT Systems. Ensure processes are in place for system maintenance & operation according to relevant regulatory authorities (GxP, financial, personal data protection, etc.).
Relationships
Reports to Supervisor, IT System Management & Validation.
Essential Functions
Systems Management:
Ensures system compliance with relevant internal SOPs & guidelines as well as external requirements (21CFR Part 11, Personal Data Protection, SARBOX, etc.)
Reviews & maintains all IT CSV validation/system decommissioning documentation in accordance to regulatory & Novo Nordisk requirements
Responsible for the system life cycle management & suggests inputs for the IT roadmap
Documents operation & maintenance of the system (incident management, contract/SLA management, data integrity/retention/archive, continuity/recovery plans)
Performs system reviews to ensure basic IT controls are in place & in control to ensure compliance/security of the system
Acts as a peer mentor providing reviews and input to documentation prepared by other team members
Ensures appropriate testing (i.e., FAT, SAT, UAT, IQ, OQ, PQ, &/or GEP) is in place to ensure IT requirements are met
Participates in root cause analysis for deviations within supported IT Systems to ensure effective corrective actions are identified & implemented
Represents IT systems in connection with audits and inspections
Documentation:
System documentation including operational manuals, system architecture, & data flow completion
Works with subject matter expert (SME) to ensure system documentation is compliant with local, corporate & regulatory regulations
Documentation of system configuration baselines
Security:
Approves appropriate access to new users & removes access as necessary
Works with IT Security/SME to ensure controls are in place & documented
Performs annual system evaluation
System Support:
Serves as the escalation point for system support
Ensures end user training is in place, as required
Prepares support agreements with internal & external sources
System Projects: Performs activities assigned within agreed timelines
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
Bachelors Degree in Computer Science or Engineering, or similar applicable technical degree in relevant field required
Minimum five (5) years of operation & maintenance of IT systems preferably within the pharmaceutical industry required
Experience with production manufacturing; IT projects & management of IT systems required
Knowledgeable & have an understanding in the following areas: required
IT frameworks such as COBIT, ITIL, GAMP, 21CFR Part 11, &/or PIC/S Annex 11 required
System development lifecycle including validation of computer systems, operation & maintenance, & decommissioning of systems required
Manufacturing processes for manufacturing areas (aseptic, inspection, assembly, packaging, utilities, & laboratories). Required
Expert in GxP documentation practices required
Proficient in basic computer skills including experience with Microsoft Office required
Ability to independently review & approve protocols & technical documents in compliance with regulatory & Novo Nordisk requirements required
Excellent oral & written communication skills required
Experience in regulatory audits & inspections required
Experience in project teams driving deliverables, tasks, & activities for computer system validation required
Expert in utilizing appropriate root-cause analysis tools & techniques required
Demonstrated expertise in planning/organizing, managing execution, checking results, & revising the work plan for complex problems being resolved by cross functional teams required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, were not chasing quick fixes - were creating lasting change for long-term health. For over 100 years, weve 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 whats possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, were 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.
Starting a career at Novo Nordisk is more than getting a job. It is an opportunity to improve the lives of millions of people living with a serious chronic disease.
Whether you are a part of supplying insulin for patients around the world, discovering the next breakthrough at one of our state-of-the-art research centres, working with us is truly life-changing.
We are a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. Millions rely on us.
We’re inspired by life in all its forms and shapes, ups and downs, opportunities and challenges. From our colleagues in the lab, working to change lives through pioneering break-through treatments, to our colleagues putting sustainability at the core of our processes and working to prolong the life of our planet, this mission to improve lives is at the core of our every action.
Change is a constant — change in lifestyle, change in technology, change all over. At Novo Nordisk, we don’t wait for change. We drive it.
We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future.
That’s why we continuously push to improve the way we work and the lives of the patients we serve, creating innovative solutions that fit the way people want to live. To accomplish this, we embrace a spirit of open-mindedness and experimentation, striving for excellence without fixating on perfection.
Our company is our people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We want to ensure that every employee can achieve a work-life balance that supports their current priorities and where they want to go next.
We value our employees for the unique skills, backgrounds and perspectives they bring to the table. We work continuously to help bring out the best in all of our people, offering opportunities for development and creating an environment of mobility within the company. We strive to offer a workplace that’s great to be in and to be from.
It is very important to us that anyone working with us feels empowered as an employee and as a person. We all should have the opportunity to act fast, make decisions and be agile.
With a career at our company, you will feel a difference right from the start. A sense of inspiration that comes from a shared belief in driving positive change for people, families and communities everywhere, and it’s a collective effort. We rely on the joint potential and collaboration of our more than 45,000 employees.
In the video above, meet Marie Darting, one of our scientists, and hear more about her work as a formulation scientist, her perspective on development plans and the impact she feels her work has on people living with a chronic disease.
We were founded in 1923 and today we are a global healthcare company headquartered just outside Copenhagen, Denmark.
Our purpose is to drive change to defeat diabetes and other serious chronic diseases, such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines , and working to prevent and ultimately cure diabetes.
With almost 100 years of experience, one of the broadest diabetes product portfolios in the healthcare industry, as well as an award-winning pipeline of innovative products, our success is built on our company values – the Novo Nordisk Way.