Qualification/Validation Compliance Manager – Quality Assurance (m/f)

Job Overview

Hookipa Biotech GmbH

Qualification/Validation Compliance Manager –
Quality Assurance (m/f)

Date posted: February, 2021
Location: Vienna, Austria

About HOOKIPA:

HOOKIPA Pharma Inc. is a clinical stage biopharmaceutical company developing a new class of immuno­therapeutics, targeting infectious diseases and cancers based on its proprietary arenavirus platform that is designed to reprogram the body’s immune system.

Position Summary:

HOOKIPA is currently working on establishing a GMP footprint (GMP manufacturing facilities and GMP labs) in Vienna, Austria. To support the related activities, the Quality Assurance department at HOOKIPA has an open Manager position, who will actively contribute to the equipment/process qualification and validation requirements and design control activities.
As part of the growing department the incumbent will mainly focus on self-dependent development of processes and procedures related to the qualification of equipment and cleanrooms. Furthermore, the candidate will take responsibility to implement these tasks into the validation master plan and keep equipment and rooms in a qualified state during routine operation. The ideal candidate has a hands-on mentality, is analytically skilled and problem-solving oriented as well as he or she is detail-oriented, driven, independent, and able to respond quickly to evolving needs. The ability to work in a fast-paced environment and professionalism are all essential behaviors for this role.
For selected topics, the Qualification/Validation Compliance Manager will act as point of contact for other depart­ments. Implementation into day-to-day practice and constant evaluation of the applied processes will be tools for the Manager to help to continuously improve the established systems.

Main Responsibilities:

  • Support/conduct FAT/SAT and IQ/OQ/PQ
  • Advise project teams, develop/review and approve qualification/validation protocols and reports.
  • Support of continuous improvement on processes and on qualification/validation projects
  • Develop and implement procedures in compliance with applicable regulations and guidelines
  • Participate in project planning, scheduling and tracking

Qualifications:

  • Relevant education in a related field (e.g. engineering, biotechnology)
  • At least 3 – 4 years of experience in qualification and validation activities and/or projects
  • Hands-on knowledge of EU GMP regulation
  • Applied technical understanding of manufacturing equipment/analytical devices/cleanroom requirements
  • Applied knowledge of creation and verification of qualification/validation documents such as plans and reports
  • Fluent in English, both spoken and written
  • Competence in Microsoft Office Tools

What we offer:

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Working in a multinational and multicultural environment
  • Help with shaping the Quality System of a growing biopharmaceutical company

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

Contact:

If you are interested in this challenging position, please send your CV including a cover letter summarizing your qualification and experiences to: [email protected]

For more information on HOOKIPA please visit www.hookipapharma.com

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