Manager – CMC Quality Representative (m/f)

Main focus: Quality Control
Date posted: 04.28.2021
Location: Vienna

Position Summary

This position is part of the Technical Development group at HOOKIPA and reports directly to the Senior Manager Quality Control. In addition to the general parts of Quality Management, this position has QC focused day to day interaction with HOOKIPA key functions, such as External Manufacturing, Project/Portfolio Management, Technical Development and Regulatory Affairs. Most importantly there is a constant interaction with the stakeholders of the CMC and project core team of our cancer programs. This position focuses on the goals and deliverables from the QM point of view (Quality Control & Compliance). The incumbent should act as the QC go-to function within the pipeline program governance structure.

Main Responsibilities

Technical project management

  • Provide overall guidance of all Quality functions (focus QC) relative to their contribution to the HB-200 and HB-300 CMC team
  • Continuously plan, review, and revise the QM relevant parts of the project plan
  • Closely monitor the development of all applicable parts of the project, identify QM implications and develop/decide on actions as well as appropriate priorities to make the project run smoothly. This includes responsibilities in supplier qualification, CMO/CLO oversight, analytical sample prioritization and testing as well as evaluation and presentation of data
  • Liaise between other Quality functions and Regulatory Affairs provide regulatory writing for QC-owned CMC parts of clinical trial applications (IB, IND, IMPD etc.) as well as External Manufacturing and Project Management to assure project progress and required product release cycle times
  • Contribute to continuous improvements of HOOKIPA’s Quality systems

General project leadership

  • Focus on project progress and success by providing all quality-related input
  • Drive input based on Quality requirements according to the ICH/EU/AMBO, i.e. keeping up-to-date with most recent project developments and implementing appropriate measures
  • Own specific Quality systems within HOOKIPA´s QC, provide SOP training to the rest of the project team members and run self-inspection of day-to-day practice aiming at continuous improvement
  • Manage the QC side of the project timelines and budget
  • Ensure intercultural awareness between the project team members

Qualifications

  • University Studies, academic degree in a Life Science area (e.g. Pharmacy, Biochemistry, Biotechnology)
  • Substantial experience in managing drug research projects with a specific Quality Management focus
  • Experience within clinical development, clinical research and clinical trial environment (biotech products preferred)
  • Particular knowledge of recombinant virus vector technology is a strong plus
  • Hands-on knowledge of EU GMP regulation
  • Fluent in English, both spoken and written
  • Valid EU working permit

What we offer

  • Strong team with dedicated and passionate scientists
  • State of the art infrastructure
  • Excellent working atmosphere
  • Opportunities for personal development
  • Working in a multinational and multicultural environment

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 3.857,- based on fulltime (40 hours per week); depending on experience and qualification salary can be negotiated. In addition, we offer a performance-related bonus payment and participation in our stock option compensation program.

Starting date: as soon as possible

Starting date: 04.28.2021

Apply Now!

Contact
Gwenaelle Kerforn Executive Director Human Resources