Quality Systems Specialist

2 months ago


Bagsværd, Denmark Novo Nordisk AS Full time

Do you want to use your skills to make good decisions, ensure regulatory compliance and validation within Novo Nordisk? Are you always looking for continued improvements by challenging the status quo? If so, we now have an open position as Quality System Specialist in our digital validation system team, the TIMS Center of Excellence (CoE).

Join us and apply today 

The position 

The digital validation system, called TIMS (Technical Information Management System), is based on ALM 12.5 and our team provides support to the validation process, the system owner and validation projects across Novo Nordisk, including guides, procedures, instructions, and training. 

As a Quality Systems Specialist and TIMS system architect you will be responsible for specifying and designing the best possible solution for digital validation and ensuring business and quality requirements. Other responsibilities include: 

Support Process Expert for validation, Process Owner and Process Owner Delegate in managing the validation process with regards to digital validation.  Support NNQ management in improving the process of digitalization.  Ensure that current and new regulatory requirements are covered by the process.  Collaborate with key stakeholders in the line of business (LoB), QA, system group, and suppliers.  Manage and drive maintenance activities within the process in close collaboration with the IT System Manager. 

Qualifications

We are seeking a Quality Systems Specialist with a strong quality mindset and experience with cross functional use of digital validation.
To succeed in this role, you have: 

Academic degree within IT, pharmacy, engineering, or other related fields  At least 5 years of experience from the pharmaceutical industry within IT, quality, or production  Experience working with IT qualification and digital validation in a regulated environment (ALM)  A flair for stakeholder management and networking at various organisational levels  Strong communication skills, with proficiency in English

With your good cooperation and communication skills you can organize and drive tasks. You have a pragmatic approach to problem solving and strong interpersonal skills. You are detail-oriented with a strong quality mindset and are a team player but are also able to work independently. You thrive on working across departments in an international organization. Great communication skills are a must. 

We are looking for a person who is team-oriented, self-driven, proactive, and responsible. The ideal candidate excels at collaborating and communicating, is solution-oriented, and demonstrates a strong commitment to actively cultivating a positive working environment. 

About the department 

The TIMS CoE is part of Investment Portfolio Quality Assurance, an area comprising around 250 highly skilled quality professionals who work to ensure early involvement in production facility investment projects, within the scope of the NN Investment Portfolio Committee. 

The primary objective of the TIMS CoE is to maintain, support, and develop the Novo Nordisk Test and Validation Tool, which has over 10,000 active users. The tool is used for validation and testing of GxP-critical and non-critical IT systems and equipment in Global IT, Product Supply, and NNI. This role is based in Bagsværd. 



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