Quality System Manager

QA · Oslo/Copenhagen, Norway/Denmark
Department QA
Employment Type Full-Time

Open position at Nykode Therapeutics as Quality System Manager for our growing QA department!


We are strengthening our QA function and are currently looking for a Quality System Manager to join us at Nykode Therapeutics! This is a unique opportunity to become part of our growing and dedicated Nykode team, allowing you to use and further develop knowledge and skills in one of Scandinavia´s leading Biotech companies. 


The position

Our QA team is now looking for an experienced and ambitious Quality System Manager. In this role you will play a leading role in designing, improving, and maintaining Nykode’s Quality Management System to secure GxP compliance. As Quality System Manager you will contribute to successful GxP inspections and partner audits of Nykode. You bring structure and a holistic approach to the role, with a strong emphasis on creating an impact and adding value to our Nykode team.


The role reports to the Head of QA and is part of a team consisting of dedicated Senior QA specialists and IT experts.

 

Job responsibilities:

  • Contributing to the design and maintenance of a compliant QMS including processes, procedures and supporting applications
  • Being process owner of selected quality processes, based on previous experiences and interests: e.g. Document Management, GxP Training, Quality Plans.
  • Being a key driver in the implementation of a company-wide document management system (EDMS)
  • Assuming system owner role when EDMS is implemented and maintain system in validated state

 

Who are we looking for?

When hiring new employees, we are looking for individuals who are inspired by the Nykode technology and our quest to unlock the future of medicine. We are eager to hire people who seek out environments that offer creative challenges and provide growth opportunities. If you feel at home in a highly collaborative, flexible, and courageous company culture, Nykode might be the right place for you. If you additionally are experienced in balancing planning, execution, and internal communication needs with a hands-on attitude, send us your application right away.

 

Education and experiences/Qualifications

  • Technical background on Master level, e.g. Master degree in Pharmacy, natural sciences or engineering
  • Experience from a QA role in Biotech or Pharma (+ 3 years)
  • Previous experience as Quality System Manager is an advantage
  • Excellent understanding of GxP requirements within EU and US as well as requirements for computerized systems.
  • Experience from managing electronic document management system (EDMS) applications
  • English proficiency at business level required

 

Applications will be reviewed on a rolling basis with a deadline on 31. May 2022

 

We are looking forward to receiving your application! We do not accept applications by mail. Should you have any further questions regarding the position, please reach out to us: recruitment@nykode.com

Thank You

Your application was submitted successfully.

  • Location
    Oslo/Copenhagen, Norway/Denmark
  • Department
    QA
  • Employment Type
    Full-Time