Quality Assurance Manager, US - Valneva

Join Valneva, a leading specialty vaccine company dedicated to developing, manufacturing, and commercializing innovative vaccines that address unmet medical needs. We’ve already brought three vaccines to market, including the world’s first and only chikungunya vaccine, and are advancing cutting-edge candidates for Lyme disease and Zika. Two of our vaccines are commercialized in the U.S.

With operations in Austria, Canada, France, Sweden, the UK, and the U.S., we’re committed to improving global public health. At Valneva, we celebrate diversity and welcome talent from all backgrounds, creating a dynamic and inclusive workplace. Be a part of something bigger—join us and make an impact!

Responsibilities

• Reporting up through the global quality department, work as primary U.S. Quality Assurance point of contact to internal and external partners (Third Party Logistics Providers), other Valneva sites

• Lead/support projects in the life cycle of Valneva’s U.S. products at external partners from a QA perspective
• Perform review, QA approval and administration of external documents applicable to the U.S. business (e.g. Reports, Deviations, Changes)
• Maintain Valneva’s Quality Systems (QMS) as they apply to the U.S. business and participate in global QMS improvement teams
• Responsible for the maintenance and continuous improvement of QMS related to the oversight of Third Party Logistics Partner (e.g. handling of external non-conformance records, documents, Change Controls, and supplier complaints)
• Tracking and reporting of key performance indicators locally and corporately
• Ensure all U.S. based employees are properly trained, maintain training files, perform training related to QMS
• Monitor DSCSA compliance both for both inbound and outbound
• Support U.S. Business Operations on quality related matters
• Provide oversight of U.S. commercial cold chain distribution

Requirements

• Bachelor or equivalent experience in a relevant field (e.g., Biotechnology, Bioengineering, Chemistry, Molecular Biology
• At least 3 years of experience within QA/ GMP regulated environment, preferably at a manufacturing site or commercial distribution site in Biotechnology / Pharmaceutical Industry
• Good knowledge of GMP regulatory framework and regulatory bodies
• Firsthand experience with cold chain distribution, preferably commercial
• Firsthand experience working with Third Party Logistics Providers
• Knowledge and understanding of DSCSA and FDA expectations for enforcement
• Excellent communication skills and able to work cross-functional, independently but also in a team
• 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
• Detail oriented, quick grasp of understanding
• Must be a US citizen or Permanent Resident
• While this role is hybrid, the candidate must reside within a reasonable commute to be in the office in the event of regulatory agency visits

Benefits

• Open, appreciative company culture with innovative spirit and attractive assignments
• Good team spirit in a strong and highly motivated team
• Health Benefits
• 401K