Position Summary

The Quality Assurance department at HOOKIPA has an open position for a Qualified Person / Senior Compliance Manager. As part of the growing department the incumbent will focus on activities for release of our investigational medicinal products. Furthermore, the successful candidate will use his/her expertise to support the QA department / development projects in maintaining GxP compliance with applicable regulations and internal procedures. 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, professionalism and ability to work in a team are all essential behaviors for this role.

• Issuance of Certificates of Compliance, QP certificates and QP confirmations
• Review and approval of master/executed batch records, specifications, CoAs and other GMP relevant documents
• Evaluation and processing of complaints, deviations, risk analyses, OOS and change controls
• Creation, review and approval of quality-relevant documentation
• Improvement of quality management system and routine processes to support the QA department in maintaining GxP compliance
• Ensure compliance of development projects with applicable regulations and internal procedures.
• Support project teams in decision making regarding aspects related to quality and/or compliance.
• Preparation, participation in and follow-up of self-inspections, audits and authority inspections

Qualifications

• Fully eligible to act as Qualified Person according to the requirements as defined in §7 of “Arzneimittelbetriebsverordnung” (AMBO 2009), the Austrian Medicines Act (AMG) and respective EU GMP regulations (Annex 16) in terms of batch certification for all territories
• Profound experience in the Quality Assurance area of a GMP-regulated pharmaceutical company preferably in the field of ATMPs and/or viral vectors
• Experience with quality requirements and regulations regarding ATMPs
• Hands-on knowledge of US cGMP and EU GMP (EudraLex Volume 4) guidelines
• 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
• Participate in shaping the Quality System of a growing biopharmaceutical company
• 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 4.828,- 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