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Quality Assurance Manager

vor 2 Monaten


Wien, Wien, Österreich Valneva Vollzeit
About Valneva

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our company has leveraged its expertise and capabilities to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease and Zika.

With operations in multiple countries, we are committed to making a positive impact on global public health. Our diverse and inclusive workforce makes Valneva a great place to work.

Job Summary

We are seeking a highly skilled Quality Assurance Manager to join our team. The successful candidate will be responsible for establishing, maintaining, and continually improving the quality assurance management system for all aspects of our activities, compliant with coordinated policies for Quality Assurance which are consistent with current GxPs, relevant Health and Safety Regulations and other relevant current legislation.

Key Responsibilities
  • Establish and maintain a quality assurance management system that meets regulatory requirements
  • Lead/support projects for global harmonization of quality systems
  • Lead/support computerized system validation projects based on GAMP5
  • Take over responsibilities within our 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
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
What We Offer
  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center, company events, myClubs and full access to LinkedIn Learning,...
Compensation

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 50.000,- gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.