Quality Assurance Manager (m/f/d)

at  Valneva

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.
We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.
Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

REQUIREMENTS

• HTL, Bachelor or Master Degree or equivalent in a relevant field (e.g., Biotechnology, Bioengineering, Chemistry, Molecular Biology, Biology)
• At least 2-5 years of experience within QA / QC / GxP regulated environment, preferably in Biotechnology / Pharmaceutical Industry
• Good knowledge of GMP guidelines and regulatory bodies
• Experience with electronic Quality Management Systems and in Computerized System Validation
• Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers (experienced, non-experienced audience)
• Ability to organize and schedule work within a busy office with experience of writing and working to SOP documentation
• Excellent computer skills, communication skills and command of German & English (spoken and written)
• Able to work cross-functional, independently but also in a team
• Proactive and solution-oriented in a fast-changing environment
• Detail oriented, quick grasp of understanding

• Establish, maintain and continually improve the quality assurance management system for all aspects of the activities of Valneva Austria, compliant with coordinated policies for Quality Assurance which are consistent with current GxPs, relevant Health and Safety Regulations and other relevant current legislation
• Lead/support projects for global harmonization of quality systems
• Lead/support computerized system validation projects based on GAMP5
• Take over responsibilities within Valneva’s electronic Quality Management System including further development of established modules and implementation of new modules on a global basis
• Lead/support digitalization projects for paper-based systems and processes
• Support the initiative to move electronic Quality Systems to Cloud and link with other systems to allow data sharing
• Actively support Quality Assurance activities related to administration & Training of Quality Systems