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Quality Assurance Manager, US

1 month ago

Bethesda, Maryland, United States Valneva Full time
Job Description

Valneva, a leading specialty vaccine company, is seeking a Quality Assurance Manager to join our US team. As a key member of our global quality department, you will be responsible for ensuring the quality of our products and processes in the US market.

Key Responsibilities:

  • Lead and support projects in the life cycle of Valneva's US products, ensuring compliance with regulatory requirements.
  • Perform review, QA approval, and administration of external documents applicable to the US business.
  • Maintain Valneva's Quality Systems (QMS) as they apply to the US 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 Partners.
  • Track and report key performance indicators locally and corporately.
  • Ensure all US-based employees are properly trained and maintain training files.
  • Monitor DSCSA compliance for both inbound and outbound.
  • Support US Business Operations on quality-related matters.

Requirements:

  • Bachelor's degree 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 the 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 ability to work cross-functionally, independently, and in a team.
  • Skills in transferring knowledge (trainings), presentation skills for miscellaneous customers.
  • Ability to organize and schedule work within a busy office with experience of writing and working to SOP documentation.
  • Detail-oriented and quick grasp of understanding.
  • Must be a US citizen or Permanent Resident.

Benefits:

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