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 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 legacy Injectable Finished Products (IFP) 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 IFP, 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
Responsible for Quality & Compliance activities for one or more Product Supply IT Infrastructure Services/Systems and covers tasks ranging from advising on quality planning, approving quality related deliverables, to the release of the Service/System for use and the subsequent operation and maintenance. The work requires close collaboration with the system managers, project management teams, and stakeholders in line of business. Must be proactive and engaging in close dialogue regularly with the IT architects, IT specialists and stakeholders across Product Supply IT including Production facilities and data centers globally to create and improve awareness on the quality and compliance requirements.
Relationships
Manager.
Essential Functions

• Follow all NN and GITO PI Standard Operating and Change Control procedures
• Perform daily Infrastructure quality management, within the rules and regulations of Global IT unit in US, Product Supply IT & Global IT in Denmark
• Ensure qualified and compliant services and systems within Production network (IT Infrastructure & IT Systems) according to Novo Nordisk Procedures. Standardize compliance of IT infrastructure services and systems
• Build yearly roadmap for compliance activities and processes, incorporating needs for local differences
• Prepare documentation and reports such as Qualification Documentation/Testing, SOPs, and Annual Compliance reports
• Review quality and compliance documents, training requirements, recommend and present within management meetings
• Ensure compliance of tasks in Novo Nordisk ITSM system including change requests, incidents, and problem management in alignment with NN Standards and ITIL best practices
• Ensure compliance in management of Infrastructure system records and compliance tasks in Novo Nordisk ITOM system including system records, scheduled compliance tasks, and configuration management
• Participate in relevant IT Infrastructure/System quality reviews for changes, testing, and documentation
• Participate in relevant vendor supplier audits, NN requirement setting, and implementation of compliance tasks
• Proactively identify compliance industry trends, assess impact to current services/systems, and implement solutions where relevant with product owners, SMEs, and/or relevant stakeholders
• Evaluate with Product Owners and Technical SMEs the feasibility of concepts and services from vendors to ensure the solutions can adapt to Novo Nordisk Quality Management System (QMS) through qualification and kept in compliance
• Define and document compliance best practices for future architectures to ensure alignment with Novo Nordisk QMS
• Serve as quality and compliance lead in the relevant projects approved by management, to include coordinating compliance activities with Project Management prior to implementation of IT Infrastructure projects
• Responsible for compliance review of ITIL processes especially Incident, Change, Release and Configuration management
• Serve as a Quality consultant during External and Internal audits, to include ensuring that the system/services are always audit/inspection ready
• Initiate and drive actions to assist in the reduction of compliance gaps via optimization and leaning of existing workflows
• Collaboration with Quality and Compliance team and product teams globally
• Follow all safety & environmental requirements in the performance of duties
• 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 Software Engineering or Computer Science from an accredited university required
• Minimum of ten (10) years of experience working within IT Infrastructure, IT Compliance and Quality consultancy services required
• Minimum of eight (8) years working with key stakeholders and decision makers outside US in a cross-functional, international environment required
• Minimum of five (5) years participating in and supporting internal audits and external inspections required
• Minimum of five (5) years of experience & establishedknowledge in Infrastructure qualification, compliance requirements in pharmaceutical industry, GxP knowledge required
• Minimum of three (3) years of experience working on mid-large scale IT projects required
• Minimum of ten (10) years of relevant technology experience with technical certifications (Software Engineering, Computer Science, Business Administration) preferred
• Experience supporting CFR 21 Part 11 validated systems required
• Communicate standards in an easy understandable form on all levels of the organization globally required
• Experience in preparation of standardized procedures, guidance documents, qualification documents, testing, and reports required
• Experience with Quality Management Systems used for change Management, Deviations, CAPAs, electronic system testing, configuration management, Audits/Inspections, and other compliance related tasks required
• Stakeholder Management preferred to include build strong relationships with Line of Business on NN manufacturing sites. Collaborate with compliance teams globally. Collaborate with Product Owners, SMEs, and Management across products/technologies globally to ensure infrastructure is maintained in a qualified state
• Ability to collaborate and communicate with external parties, primarily with vendors, consultants, and customers, including regulatory authorities required
• Must be able to be self-managed and demonstrate astrong personal drive to include being highly motivated and an excellent collaborator with colleagues and peers towards delivering excellent performance and results including continuous improvement
• Ability to analyze and solve complex issues in a timely and structured manner
• Ability to demonstrate a global mindset required
• High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones
• Must be able to demonstrate aninnovative mind set and come forward with improvement proposals regarding IT Compliance & Quality, IT Infrastructure & Support areas
• Strong general business understanding preferred
• Any internationally recognized Quality certification preferred
• Agile skills including the following: Working in an Agile way and support the processes e.g., DSU, DEMO, PI Planning; Knowledge on Agile principles and methodology; Knowledge on Agile tools e.g., Scrum, Kanban, SAFe; Understanding of the Agile mindset and culture, a plus

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.