Manager - Quality Assurance (f/m/d)

Position Summary

Position Summary: The successful applicant acts as point of contact for CMC related topics and represents Quality Management in the respective project subteams. Depending on the project specifics and individual experience, the position holder will be responsible for both QA- and QC-related topics, or work on one of those areas. Furthermore, the incumbent takes over responsibility for operational quality tasks related to his role in close collaboration with other subteam functions.

Main Responsibilities:

• Act as Quality point of contact for other departments for CMC-related topics.
• Responsible for project related quality tasks, such as:
  • Change owner, subject matter expert in change committees, reviewer and/or approver of changes
  • Deviation owner, review and/or approve deviation reports
  • Preparation and review of SOPs
  • Preparation and review of specifications, stability plans and CoAs
  • Oversight over validation and qualification activities of external partners
  • Review and approval of master batch records and executed batch records
  • Review and approval of relevant CMC parts of clinical trial applications (IB, IND, IMPD etc.)

Qualifications

Qualifications & Skills:

• Education in technical or biosciences (University or FH)
• Self-motivated personality with strong interpersonal skills, comfortable with working in fast-changing environments. Can handle adversity and ambiguous situations, with the strong ability to prioritize and adapt.
• Previous experience in the pharmaceutical industry, preferably in the field of Quality and Compliance, work experience in a startup or clinical stage environment is an asset.
• Hands-on knowledge of applicable regulations and guidelines
• Fluent in English, both spoken and written, Microsoft Office user skills
• Valid EU working permit

What we offer

What we offer:

• An excellent working atmosphere
• Attractive salary package
• Hybrid work model
• Strong, motivated team with dedicated and passionate employees
• State of the art infrastructure
• 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 4.235, -  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