Senior Operations Analyst - GITO

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 a