Are you passionate about quality? Do you like to work with Quality Assurance of Computerized Systems and continuous improvement of processes? Do you want to be a part of a global organization with high professional standards and a great working environment?Then we have an exciting job opportunity that may be your next career move.
Ambu develops, manufactures and sells Medical Devices. Millions of patients and healthcare professionals depend on the functionality and performance of Ambu’s products worldwide. Come join a fast growing and exciting Medical Device company with an ambitious strategy.
We are looking for a QA IT Compliance Manager, who can take up this exiting position in the Corporate QA Systems department.
As QA IT Compliance Manager you will take an active role as business partner for the two VP areas under Corporate IT in Ballerup: Corporate Business IT and Corporate Business Analytics & Data Management. You will facilitate understanding of quality requirements related to validation and maintenance of IT GxP systems and participate as QA representative in a long and ambitious pipeline of Corporate IT projects for new and existing global IT systems in Ambu.
You will be part of a strong quality culture, where we keep ahead of new regulatory requirements and constantly strive for improvements. This sets high demands to your experience, change management skills, as well as quality and business understanding.
You will work from our Headquarters in Ballerup and join a QA Systems team of 6 colleagues in Denmark and you will refer to the Director of Corporate QA Systems.
A global job with impact
As QA IT Compliance Manager, you will get a varied working day in a dynamic organization where you get to influence Ambu’s IT GxP Systems and processes as well as your own daily tasks and responsibilities.
Your key responsibilities will be to:
- Have a business partner role for Corporate IT in relation to the IT owned processes within Ambu QMS, and drive compliance of computerized systems in close cooperation with Corporate IT.
- Facilitate understanding of requirements for validation and maintenance of IT GxP systems, and support continuous improvements of IT processes and IT project model in close cooperation with Corporate IT.
- Participate as QA rep in Business IT projects for implementation, upgrades, improvements & roll-out of global Ambu GxP Business systems:
- Evaluate IT supplier validation documentation
- Audit IT suppliers as part project
- Validation strategy for internal validation
- QA review and approval of validation documentation
- Act as Internal & Corporate Auditor
- Participate in Inspections by authorities
- Define and drive improvements for more effective use of Ambu’s Agile PLM System and processes (general system use, processes owned by QA Systems and processes owned by other areas of the company)
Experience and passion
To succeed in the job, you must have a relevant academic background - e.g. a MSc / BSc in IT engineering or similar, as well as 6-8 years’ experience from working with quality assurance of computerized systems within a Medical Device or Pharmaceutical organization.
Documented experience from working with computerized system compliance and IT validation, either in QA or in IT – preferably in a role with focus on business partnership between QA and IT.
Extensive knowledge of regulatory requirements for computerized systems and validation – ISO13485, GAMP 5, 21 CFR Part 11 etc.
It is considered an advantage if you have demonstrated experience as an internal auditor, as well as experience with driving and participating in projects within a Quality organization.
As a person, you have a good business understanding and are confident in communicating quality requirements and facilitating effective implementation in an organization. You are a good decision maker, and a strong communicator, focusing on respectful dialogue with your colleagues. You are collaborative and have a business partner mindset.
It is important that you have a strong drive, take lead of different quality initiatives, and that you can work independently. You take pride in good collaboration, and you are open-minded and see possibilities even when daily life is dynamic and hectic.
You are structured and good at prioritizing, planning and finalizing your tasks.
Ambu is a global company and English is our corporate language, which requires that you speak and write English at a relatively high level.
Ambu – a visionary and international workplace where your effort matters
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us, you will get the opportunity to work in an international head office with an informal working environment.
We offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
How to apply
If you are interested in the position, please apply as soon as possible. Note that candidates will be evaluated and invited for interviews on a continuous basis. This job ad might be online until July 20, 2020, but once we have found the right candidate, this ad will no longer be online.
If you have any questions about the position you can contact Director of Corporate QA Systems, Vibeke Lillie Gadsbøll, telephone no. +45 22 34 24 14.
Your application will be treated with confidentiality.
Please write in your application that you've seen the job at Jobfinder.