Senior QA Specialist

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

About the role

 

We are strengthening our QA function, and are currently looking for a Senior QA Specialist to join us at Vaccibody! This is a unique opportunity to become part of our rapidly growing, exciting and dedicated Vaccibody team, allowing you to gain knowledge and skills from one of Scandinavia´s leading Biotech companies. 

 

Job responsibilities

  • Provide guidance and support to the organization in GCP and other quality related matters
  • Responsible for writing and editing documents needed for the Quality Management System
  • Quality oversight of internal clinical research as well as outsourced activities
  • Responsible for overall SOP training of Vaccibody personnel in at all times relevant processes and procedures in collaboration with departmental leads
  • Assist with establishing the audit program (external and internal) in cooperation with relevant VB personnel
  • Perform audits in the clinical area
  • Assist with the preparation, coordination and management of regulatory inspection activities
  • Provide input and change management for quality improvement processes

 

Location

 

You are located in either Oslo-area, Norway or Copenhagen-area, Denmark.


Deadline: Rolling basis 

 

Who are we looking for?


When hiring new employees, we also look for the individuals who are inspired by Vaccibody’s entrepreneurial spirit and whom we think would be a good fit with our collaborative and inclusive company culture. We believe that you are driven by an eagerness to learn, you are proactive and not afraid of facing challenges. Moreover, you enjoy working together with other people in cross-functional team structures and appreciate an international environment.

 

Education and experience requirements


  • Master’s degree within medical, biological, pharmaceutical science or equivalent
  • Extensive knowledge of GCP
  • Experience as auditor is an advantage
  • Experience from pharmaceutical product development
  • Excellent English communication and presentation skills (written and verbal)


Why join our Vaccibody team?


At Vaccibody, we offer a fun and dynamic international working environment. The people are at the heart of our organization, which is why we always keep striving to offer a workplace where we cheer each other on and find motivation. Your skills and competencies are unique and to ensure continued development our aspiration is to provide you with good opportunities for personal growth. We care about each other.

About us

Our company was founded in 2007 and has since then, become one of the world’s most exciting Biotech companies, rapidly growing. Today we are counting more than 60 amazing employees within medical and development teams, manufacturing, bioinformatics, and research teams. We use the Vaccibody technology to generate therapeutics with best-in-class potential to treat cancers with a high unmet medical need. Furthermore, we also focus our research on infectious diseases and immune tolerance. We closely collaborate with Roche and Nektar Therapeutics. And we are proud to have entered into a worldwide license and collaboration agreement with Genentech, a member of the Roche Group, to develop individualized neoantigen cancer vaccines.

Thank You

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