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IT Compliance Specialist: Raise the bar for data integrity

Bavarian Nordic A/S



Would you like to set high standards in IT Compliance and help define the organizational work through improvements of our IT QMS? Do you want to raise the bar for data integrity across Bavarian Nordic? Then a position as IT Compliance Specialist in our newly established IT Compliance Support team might be the position for you!

Join our transformative journey
At Bavarian Nordic we work to develop innovative and safe vaccines to treat and prevent cancer and infectious diseases. Our aim is to improve health and quality of life for children and adults around the world. We hope that you will share this mission with us.

Bavarian Nordic has with our recent acquisition of two established commercial vaccines and the FDA-approval of our smallpox vaccine embarked upon a truly transformative journey to become one of the largest pure play vaccine companies, improving and saving lives by excelling in R&D innovation, manufacturing and commercialization. With the completion of our fill and finish facility at Kvistgaard we will be able to carry out all parts of the chain in vaccine manufacturing.

As a result, there is an increased demand for new IT GxP services which increases our need for support in validating IT systems and in ensuring data integrity for GxP data-generating processes across our sites in Denmark, Germany, US and Switzerland. Therefore, we are now looking for an IT Compliance Specialist that can help us with core tasks within IT compliance.

Define and improve our work with IT QMS
We are looking for an IT Compliance Specialist for our newly established IT Compliance Support team that currently consist of 3 dedicated employees.

The team is responsible for providing validation expertise in the business-critical IT GxP projects across the organization. Furthermore, the team owns the part of QMS pertaining to computerized systems validation and data integrity, and therefore you will also participate in defining, maintaining and improving the related corporate procedures.

You will work in close collaboration with the IT Department, giving input to the planning of IT system and infrastructure implementations while also providing advice on compliance-related matters.

You will report to the manager for IT Compliance Support.

Act as Validation Responsible for IT GxP Systems
We are looking for an IT Compliance Specialist for our newly established IT Compliance Support team that currently consist of 3 dedicated employees headed by the Manager for IT Compliance Support.

The team is responsible for providing validation expertise in the business-critical IT GxP projects across the organization. You will therefore spend most of your time fulfilling the role of validation responsible in one or more IT GxP Projects, with responsibility for:

  • Writing or facilitating validation deliverables (VPP, URS, RA, Protocols etc) together with Line of Business
  • Provide support and training in IT Compliance and Data Integrity
  • Act as liaison between IT, the line of business owners and QA
  • Assist in writing SOPs, Change Requests, Deviations and CAPAs
  • Take active part in improvement projects in the QA department such as implementation for the PQS IT platform owned by QA ( the platform is based on Veeva Vault)

Furthermore, the team owns the part of QMS pertaining to computerized systems validation and data integrity, and therefore you will also participate in defining, maintaining and improving the related corporate policies and local IT procedures. Since we are still a newly established function you will have the opportunity to get a lot of influence in defining and implementing our IT QMS and Data Integrity strategy.

Pro-active and independently driving initiatives
To succeed in this position the following experience and qualifications are required:

  • Min. 3 years’ experience with qualification and validation of IT systems within the pharmaceutical/biotech industry
  • You have a good understanding of GxP data integrity principles and data lifecycle within biotech product development and know how to communicate and apply these principles in your everyday work
  • Preferably you have experience with translating requirements and executing qualification/validation of larger corporate IT systems, such as ERP, PQS, RA, Clinical data mgt etc.
  • It would be an advantage if you have experience with the Veeva Vault platform, though this is not a requirement.
  • You are fluent in English both verbally and in writing.

As a person you are used to independently drive initiatives where the road ahead is not always clear. You thrive in an outgoing role and at the same time you can navigate in an environment of diverse stakeholders with different agendas and divergent goals. You thrive by planning and setting an honor in implementing and performing tasks according to the plan. You are detail-oriented and a strong ambassador of a quality mind-set, but also able to apply pragmatic approaches and seeing things from a different angle when needed.

We offer…
an exciting position in an international company with a unique technology and manufacturing process within vaccine/biologic production. As IT Compliance Specialist you will be in contact with many different departments across our three sites and you will be working in an open culture, where everybody is working in the same direction and where there is room for ideas and independent action. The company is very agile by nature and we aim for speedy implementations and for applying a pragmatic approach to reaching the right level of quality.

Caught your interest?
If you are interested in the position, we look forward to receiving your application via our recruitment system as soon as possible. Just click the Apply-Button on the right side of the page and you will be redirected to our application form.

We are interviewing on an ongoing basis.

Further information
If you are missing some job details do not hesitate to contact Manager, Kim Stenbo Nielsen on Mobile no. +45 6130 5638 or by e-mail: kim.nielsen@bavarian-nordic.com.

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Bavarian Nordic A/S - hurtigt overblik


Placering
Hejreskovvej 10A
3490 Kvistgård
Logo: Bavarian Nordic A/S
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