Senior Quality System Professional

Do you have a strong drive and excellent quality and validation skills? Are you passionate about ensuring cutting-edge technologies adhere to the highest standards of regulatory compliance? At Novo Nordisk, we are looking for a Senior Quality Systems Professional to join our team and validate advanced IT systems, including those on the Veeva Vault Platform, ensuring they meet GxP standards and regulatory requirements.

Join us in our mission to drive healthcare innovation while maintaining the utmost integrity and quality in our IT infrastructure!

The Position

The Senior Quality Systems Professional will be responsible for defining and executing validation and qualification strategies for GxP systems and integrations supporting critical quality processes.

Other responsibilities will include:

• Participate in change and release management process for QualityDocs
• Participate in process of managing and refining changes to establish clear user requirements described in features
• Collaborates with IT validation partners to develop and execute validation plans, reports, test strategies, and execution protocols.
• Conducts business risk assessments, IT requirements risk assessments, functional assessments, and data integrity assessments to ensure system compliance and reliability.
• Ensures systems remain in a validated state, perform troubleshooting, handle incidents and maintain accurate system documentation and instructions.
• Plays a role in mergers and acquisitions on QMS by collaborating with Line of Business and migration partners.

Qualifications

On a personal note, you excel in interpersonal communications, enabling you to work effectively with diverse teams and stakeholders. Your pragmatic thinking allows you to balance compliance requirements with practical solutions, ensuring both regulatory adherence and operational efficiency.

In addition, you have:

• Holds a Master’s degree in Information Technology (IT), Computer Science, Information Systems, Engineering, or a related field, with strong technical expertise.
• Possesses a deep understanding of relevant regulations, standards, and guidelines critical to compliance in regulated industries.
• Extensive experience in validation methodology, including developing and executing validation protocols, creating validation plans, performing risk assessments, and ensuring compliance.
• Demonstrates strong project management skills, with the ability to plan and track tasks, manage compliance activities, and deliver high-quality results on time.
• Skilled in content and data migration between regulated IT systems, with knowledge of Veeva Vault and Safe Agile methodologies as an added advantage, and fluent in English.

About the Department

You will be joining Vault Quality – a department with 12 passionate and experienced professionals. The team is part of the organisation Integrated Quality Data & Technology, and you will work in Bagsværd, Denmark. The Integrated Quality Data & Technology area consists of around 70 dedicated employees in Denmark and India. Our area is at the forefront of integrating advanced technology solutions with regulatory compliance and quality assurance within Novo Nordisk.

You will be part of the Vault Quality Agile Release Train (ART) which consists of around 70 engaged team members working in 6 Scrum teams, comprised of both IT and the line of business. Knowledge sharing with peers and learning is an integral part of the job, and you will be able to build on our collective experience in your own development.

Working at Novo Nordisk   

Novo Nordisk is a global healthcare company headquartered in Denmark. For over 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that.

We are proud of our people too, and we employ more than 65,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk. 
 

Contact

For further information, please contact Maria Winskov Rasmussen at [email protected]

Deadline

28 January 2025.

Please note that we will be assessing applications as we go, so we recommend applying as soon as possible.

You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.  

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.  

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.