Director - Clinical Quality Assurance (m/f/d)

Position Summary

The Clinical Quality Assurance Director is responsible for all aspects of Clinical Compliance and Quality Assurance Management of the Clinical Trial process within HOOKIPA. It will provide leadership and oversight for all QA activities and be the QA point of contact for GCP for all external partners and regulatory bodies. The activities will include the ownership of the Quality Management System working with a risk based approach, SOPs creation and CAPA management as well as internal and external audit management. It will require judgement and business acumen to advise internal stakeholders and look to build robust collaboration across the Clinical Function. It will be the key contact in managing regulatory inspections conducted in the EU and worldwide. Furthermore, the role will identify areas of process improvement opportunities and drives implementation of optimized procedures in close collaboration with other functions and departments. This role will significantly contribute to shaping the future of Quality Assurance within an evolving organization. It is an individual contributor position with main stakeholders in Clinical Development, Clinical Operations, Regulatory Affairs and Quality Assurance. The position holder directly reports to the VP of Quality.

• Assure best day-to-day GCP practices within HOOKIPA’s quality management system
• Implement and own a “GCP Standards” meeting which ensures escalation of GCP related topics within HOOKIPA
• Author, review and approve GCP specific SOPs and associated documents
• Propose training requirements of and support training assignments to GCP employees
• Develop and implement GCP audit program, as well as conducting internal and external audits
• Act as GCP expert and provide GCP guidance and support to other functions and departments
• Lead GCP QA within Quality Management and clinical trial related projects
• Develop and lead a team capable of timely fulfilling routine tasks
• Constantly monitor the GCP compliance status, identify any gaps and develop mitigation measures and/or action plans in cooperation with relevant functions
• Propose and support implementation of continuous improvement of established processes
• Collaborate with other GxP functions if cross-functional processes need to be set up and/or adapted

Qualifications

• Excellent and cross-cultural communication skills
• Ability to manage internal and external stakeholders, without the need for a reporting hierarchy 
• Profound experience in a clinical trial function within a GCP regulated pharmaceutical/life science company/clinical trial sponsor or trial site
• Hands-on knowledge of GCP regulations, working knowledge of Biotech Cell and Gene development would be advantageous is an asset
• Thorough knowledge of Pharmaceutical Quality Management Systems (PQMS), ability to understand the complexity of clinical development in cell and gene therapy
• Fluent in English, both spoken and written
• Education in natural/life sciences (university up to PhD/MSc)
• Competence in Microsoft Office Tools
• 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
• Hybrid working model

We are required by Austrian law to post a minimum salary. The minimum monthly gross salary for this position is EUR 5.438,- 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(at)hookipapharma.com