Manager – Quality Assurance (m/f/d)
Datum der VeröffentlichungMärz 6, 2023
Manager – Quality Assurance (m/f/d)
Date posted: February 2023
Location: Vienna, Austria
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.
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.
- 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 & 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:
- 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
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: [email protected]
For more information on HOOKIPA please visit www.hookipapharma.com
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