Job Description

Department Name \xe2\x80\x93 DD&IT \xe2\x80\x93 R&ED Research & Early development

At Novo Nordisk, we strive to be at the forefront of digital healthcare and to succeed with this, we need many bright minds. Working directly or indirectly with all parts of Novo Nordisk Globally, you will play a significant part in leading Novo Nordisk towards the future of digital healthcare securely. We are looking for a Business Analyst II for our Global Drug Discovery department. Join a growing team, working in an international environment. Apply now!

About the department

Digital Data & IT GBS (Global Business Service) was established in February 2010 as an integral part of Digital Data & IT in HQ (Head Quarter). From the beginning in 2010, the unit has grown to 800+ employees till date. The main role of DD&IT GBS is to \'manage\' IT, which includes System Management, Project Management, Infrastructure Management, Compliance Management, Security Management, Process Management, etc.

In DDIT RED GBS, we partner globally with R&ED LoB to achieve scientific aspiration. We provide timely, best in class, regulated and non-regulated IT solutions, infrastructure, and system management across the R&ED value chain. We manage more than 20+ IT systems and the department consists of Agile DevOps members, System Managers, Validation SMEs, cloud engineers and Business Analysts.

The Position

As a Business Analyst II you will be responsible for performing various tasks related to IT System Validation. You will be defining and executing qualification strategy for IT System both in the project and operations phase. Perform qualification activities including Implementation plan, Implementation report, Design Review, Test strategy and execution. You will be entrusted with the below responsibilities :

• Performing assessments such as Supplier assessment, IT risk assessment, functional and data integrity assessments etc. Work with improvements of the qualification process and the vendor cooperation.
• Support SOP updates related to qualification. Guide product teams on deviations. Support System Manager and Product Owner in creation and maintenance of service documentation and instructions. Help the teams with audits and inspections including closing any identified finding.
• The IT Validation and Compliance responsible is responsible for ensuring validated state of the system by performing Periodic Reviews, addressing deviations, creation and maintenance of system documentation and instructions in cooperation with System Managers and IT responsible when needed.
• Support IRM Service Manager to build and stabilize IRM service. Support local risk managers. Support IRM service expansion in existing and new business areas. Conduct ITRAs as part of IRMs to support the team and business areas, whenever needed.

Qualifications

• Bachelor\xe2\x80\x99s / Master\xe2\x80\x99s degree in relevant with 4 to 5 years of experience working within IT.
• 4 years of experience with end-to-end validation, Test cases, Testing, System qualification, compliance requirements in pharmaceutical IT industry.
• Good understanding of GAMP 5 Guide (GAMP 5) and various Regulatory requirements including 21 CFR part 11, EU Annex 11.
• ITIL processes especially Change, Release and Configuration management.
• Experience with working with Agile framework (Preferred).
• Ability to collaborate and communicate with stakeholders, both internal and external at all levels.

Working at Novo Nordisk

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That\xe2\x80\x99s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working towards something bigger than ourselves, and it\xe2\x80\x99s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we\xe2\x80\x99re life changing.

Contact

To submit your application, please upload your CV online (click on Apply and follow the instructions).

Deadline

13th October 2023

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\xe2\x80\x99re life changing.

Novo Nordisk