Validation Lead in LABS

Category:  Information Technology & Telecom
Location: 

Bagsværd, Capital Region of Denmark, DK

   

In Novo Nordisk, we have a passion for improving patients’ lives all over the world. Will you help us bringing that passion to life? Would you like to further develop your expertise within validation and quality control? We are looking for a skilled Validation Lead to help drive the digital transformation of Novo Nordisk. You will be part of the LABS department.

 

About the role

 

As a validation lead you will be responsible for defining the validation strategy, validation planning and reporting in relation to a specific implementation or upgrade of an IT system with GxP (healthcare) impact. You will work closely with the product owners, Line of Business (LoB) and other stakeholders to understand the scope of validation and act as liaison with LoB QA and ITQA.

 

This is a job for those who are excited to work with technologies, validation, testing and quality control in agile IT projects. Your key tasks will include:

 

  • Participation in large scale IT projects as the validation expert thus responsible for execution of validation and quality control activities
  • Taking responsibility for all validation activities for the project(s) e.g., planning, documentation, coordination, and reporting and ensuring that these are executed effectively.
  • Helping develop and optimize our approach to validation and quality control work, ensuring we test and validate the right things at the right level, supporting a risk-based approach to testing.
  • You will be responsible for performing various assessments such as Supplier
  • Assessment and IT risk assessment or facilitating the workshops for these activities.
  • You ensure the validated state of the system(s) by performing periodic reviews, addressing deviations, creation and maintenance of system documentation and instructions in corporation with the system managers and IT responsible when needed
  • Ensuring that systems follow relevant internal and external regulatory requirements.

You will also participate in audits and inspections including finding solutions to compliance gaps identified during audits and inspections

  • Help development teams develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans

 

Required Qualifications

 

Core skills

• You have completed a Bachelor or Master’s degree within Computer Science, Engineering, Software Development or other related fields.
• Alternatively, you have proven and extensive experience within IT Validation from the pharma industry or other regulated industries.

• You are experienced in working with large scale projects and validation, preferably working in an agile manner.

• You are quality minded with good ability to execute within deadlines

• Stakeholder- and change management

• You are process oriented and have good documentation skills

 

Personal skills

  • Can work independently but also collaboratively
  • Good communication and facilitation skills
  • Fluent in English
  • Curious and stays up to date with latest technologies

 

You are proactive and thrive in a challenging, dynamic, and ever- changing environment. You can handle several tasks at a time and keep an ongoing focus on results. Being open minded and positive and have the ability and feel confident to collaborate with external parties, customers, vendors, and consultants. In addition, you must have strong work ethic and willingness to take responsibility and drive success.

 

About the department


LABS is a part Digital Data & IT Product Supply organisation which has approx. 850 employees based in Denmark, India, US, China, France and Brazil. The strategic objective of the unit is to be the IT partner for the business, ensuring that we provide the IT solutions and support to the Novo Nordisk production solution as well as supply chain needs worldwide. In LABS you will be part of a highly engaged department developing and improving IT systems which are core to the laboratory processes in Novo Nordisk. Though you will be working with a lot of colleagues from around the globe, the job location will be in Denmark.


Working in Novo Nordisk

 

At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy, we offer our employees opportunities for continuous growth.

Contact


For further information, please contact Lilian Juma Lausen +45 3079 1849

 

Deadline

 

February 5th, 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’re life changing.