IT Validation and Compliance Partner

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 [xxxxx], we are looking for an IT Validation and Compliance Partner 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 IT Validation and Compliance Partner will be responsible for defining and executing validation and qualification strategies for GxP systems and integrations supporting critical quality processes. The role will be working with activities involving migration of data into Vault Quality as well as supporting the validation and implementation of Artificial Intelligence (AI) use cases.
Your tasks include:

In collaboration with the Vault Quality Validation Lead and other IT validation and compliance partners, you will develop and execute comprehensive validation plans, reports, design reviews, test strategies, and execution protocols.

Conducting vendor assessments, IT risk assessments, IT requirements risk assessments, functional assessments, and data integrity assessments are part of your daily responsibilities.

Ensuring that systems remain in a validated state through reviews, troubleshooting deviations, and maintaining system documentation and instructions is an important part of your job.

Your responsibilities also include ensuring compliance with internal and external regulatory requirements and addressing compliance gaps.

In connection with Mergers & Acquisitions you will work closely with the Vault Quality Scrum teams responsible for QualityDocs and the selected migration partner to plan and execute data migration activities, ensuring all requirements are met.

Collaborating with Artificial Intelligence specialists, QA experts, and IT QA to support Artificial Intelligence use case validation is an integral part of this job.

Qualifications:

Master’s degree in information technology (IT), Computer Science, Information Systems, Engineering, or a relevant field.

Deep understanding of relevant regulations, standards, and guidelines.

Experience in validation methodology, including developing and executing validation protocols, creating validation plans, and performing risk assessments.

Project management skills, including the ability to plan and track tasks, manage compliance activities, and deliver high-quality results.

Experience with content and data migration between regulated IT systems.

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. About the Department
You will be joining Quality IT – a department with 9 passionate and experienced IT professionals. The team is part of the organisation Digital, Data & IT Staffs (DD&IT Staffs) and you will work in Bagsværd, Denmark. The DD&IT Staffs area consists of around 100 dedicated employees in Denmark and 110 in India. Our area is at the forefront of integrating advanced technology solutions with regulatory compliance and quality assurance within [xxxxx].
Via your role as IT Validation and Compliance Partner, you will also be part of the Vault Quality Agile Release Train (ART) which consists of around 70 engaged team members working in 5 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 [xxxxx]  
[xxxxx] 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 [xxxxx].
Contact
For further information, please contact Christina Nøddeskov Andersen at [xxxxx] Deadline
16 June 2024 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. At [xxxxx] 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.