Computerized Systems Validation Manager – Quality Assurance (m/f/d)

bei HOOKIPA Biotech GmbH Wien vor 4 Tagen

Computerized Systems Validation Manager
- Quality Assurance (m/f/d)

Date posted: August 18, 2022
Location: Vienna, Austria

About HOOKIPA:

HOOKIPA Pharma Inc. (NASDAQ: HOOK) is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies that mobilize and amplify targeted T-cells to address unmet needs in cancer.

This leveraging its proprietary, versatile platform to engineer a broad pipeline of differentiated arenaviral therapeutics. These novel immunotherapies induce robust antigen-specific killer T- cells to a broad range of self and non-self antigens, including viral antigens, tumor-associated antigens and neoantigens. HOOKIPA's platform technology uses replicating viral vectors based on the target cancer, with the potential to induce killer T-cell response levels previously not achieved by other immunotherapy approaches.

HOOKIPA's pipeline includes wholly-owned investigational arenaviral immunotherapeutics targeting HPV16+ cancers, prostate cancer, KRAS-mutated cancers (including colorectal, pancreatic and lung), and other undisclosed projects. In addition, the company aims to develop functional cures of HBV and HIV in collaboration with Gilead.

Position Summary:

The Computerized Systems Validation Manager within the Quality Assurance department will be subject matter expert and QA single point of contact for all topics related to computerized systems which are used within the context of GxP at Hookipa Biotech GmbH. He/She is responsible for computerized systems validation projects and system maintenance. He/She also mentors the IT department regarding all activities which might affect GxP-relevant computer systems or processes.

Main Responsibilities:

  • Development and maintenance of the current Computerized System Validation process
  • Execution of gap analysis and risk assessments for existing and new computerized systems to ensure compliance with FDA 21 CFR Part 11 and EU Guide to GMP Volume 4 - Annex 11
  • CSV project manager for the implementation of a new eQMS system
  • Act as subject matter expert for CSV during regulatory inspections
  • Perform training of existing and new employees on the use of computerized systems within the pharmaceutical industry
  • Author, review and / or approval of documents such as specifications, SOPs, validation plans and contracts which are connected to computerized systems (e.g. IT-Security, backup and disaster recovery, SLA)
  • Management of computerized systems inventory
  • Support of IT-department for maintaining the qualified status of IT-infrastructure

Qualifications & Skills:

  • Technical education (HTL, FH, TU)
  • Minimum 4 years experience in the field of pharmaceutical industry related to qualification and computerized systems validation
  • Experience in planning, implementing, managing and sustaining the validated state of computerized systems
  • Experience in the implementation of IaaS-, PaaS- and SaaS-systems within the pharmaceutical industry
  • Experience within GCP/ GCLP is a plus
  • Fluent in English, both spoken and written
  • Valid EU working permit

What we offer:

  • Strong team with dedicated and passionate employees
  • State of the art infrastructure
  • An excellent working atmosphere
  • Opportunities for personal development
  • Employee benefits such as health screening, public transportation card, Sodexo pass
  • 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 4.112,-- 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 (m/f/d) are interested in this challenging position, please send your CV including a cover letter (summarizing your qualification and experiences) as well as your credentials to: talent@hookipapharma.com

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

Kontakt

HOOKIPA Biotech GmbH

Helmut-Qualtinger-Gasse 2/2
1030 Wien

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