A unique opportunity to join our Vaccibody team

The position

We are strengthening our QA function, and are currently looking for a Director, Head of QA, and 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.

We will build a complementary QA-team covering GCP, GLP and GMP. The Head of QA and the Senior QA specialist will together be responsible for building a QA strategy and a quality management system fit for the new phase Vaccibody is moving into. The QA department will be working in close collaboration with the other functions at Vaccibody to ensure quality is an integral part of all work performed within the company. The QA department will also be responsible for ensuring compliance with all applicable regulatory requirements across the GxP area.

Job responsibilities

• Drive the Vaccibody QA strategy in accordance with regulations, organizational needs and changes
• Provide guidance and support to the organization in GxP and other quality related matters
• Responsible for the expansion, update and maintenance of the Quality Management System, including deviations, change controls, CAPAs and metrics in accordance with the organizational needs
• Responsible for overall SOP training of Vaccibody personnel in at all time relevant processes and procedures in collaboration with departmental leads
• Responsible for writing and editing documents needed for the Quality Management System
• Set up and drive a yearly audit program (external and internal) in cooperation with relevant VB personnel
• Assist with the preparation, coordination and management of due diligence and regulatory inspection activities
• Provide input and change management for quality improvement processes

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. You have a business-oriented mindset and your analytical thinking helps you excel in your field.

For candidates to succeed in these positions, we believe that you have a solid scientific understanding and knowledge of the pharmaceutical industry/Biotechs and the operational mode at Vaccibody. You have significant experience and track record within drug development activities and processes – from one or more of the relevant GxP areas.

Education and experience requirements

• Master degree within medical, biological, pharmaceutical science or equivalent
• For Director, Head of QA minimum 10 years of pharmaceutical/biotech industry experience, whereof at least 5 years should include QA experience from global/corporate drug development projects
• For Senior QA Specialist, minimum 7 years of pharmaceutical/biotech industry experience, whereof at least 3 years should include QA experience from global/corporate drug development projects
• Extensive knowledge of one or more of GCP, GMP or GLP
• Solid experience of the regulatory framework covering all phases of drug development
• Experience from Health Authority interactions (FDA and EMA)
• Experience from vaccine, ATMP or biological product development
• Excellent English communication and presentation skills (written and verbal)

Location

The ideal candidates will be positioned either in Oslo or the Medicon Valley region of Copenhagen/Malmo

Why join our Vaccibody Team?

Vaccibody is a clinical-stage biopharmaceutical company, founded in 2007. Since then, we have become one of the world’s most exciting Biotech companies, rapidly growing, today counting more than 50 amazing employees with medical and development teams, manufacturing, bioinformatics, and research teams. We are dedicated to the discovery and development of novel immunotherapies, and are using the Vaccibody technology to generate best-in-class therapeutics to treat cancers with a high unmet medical need. Furthermore, we also focus our research on infectious diseases. We closely collaborate with Roche and Nektar Therapeutics, and 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.

At Vaccibody, we develop cutting-edge, targeted DNA vaccines for clinical use, based on a deep understanding of immunological principles. Vaccibody’s vaccines specifically target Antigen Presenting Cells. By intelligent design, Vaccibody’s vaccines can be tailored to induce the desired immune response profile correlating with protection for each specific disease with any given antigen.

The people at Vaccibody are at the heart of our organisation, which is why we always keep striving to offer a workplace where they can have fun and find motivation. We provide our employees with opportunities for personal growth in close collaboration with our dedicated and experienced teams. Furthermore, we ensure that proper training is provided and support them in managing their work-life balance. Eager to learn more about our Team and our work? Please visit us at Vaccibody.com

We look forward to receive your application!