Senior Quality Assurance Manager

4 weeks ago

Bethesda, Maryland, United States Valneva Full time
Job Title: Senior Quality Assurance Manager

We are a leading vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our team is committed to making a positive impact on global public health.

Key Responsibilities:
  • Work as primary Quality Assurance point of contact to internal and external partners, including Third Party Logistics Providers and other Valneva sites.
  • Lead and support projects in the life-cycle of Valneva's products at external partners from a QA perspective.
  • Perform review, QA approval, and administration of external documents, such as reports, deviations, and changes.
  • Take over responsibilities for certain Valneva's Quality Systems.
  • Responsible for the maintenance and continuous improvement of QM-Systems related to the oversight of external partners/Third Party Logistics Partners.
  • Interact with QP's and other internal stakeholders regarding Quality Oversight of Third-Party Logistics Partners operations for marketed products.
  • Track and report key performance indicators.
  • Participate in the compilation of Product Quality Reviews.
  • Contribute to the continuous improvement of the quality assurance management system for all aspects of the activities of Valneva USA Inc., compliant with coordinated policies for Quality Assurance which are consistent with current GMDPs, relevant Health and Safety Regulations, and other relevant current legislation.
  • Actively support Quality Assurance activities related to administration and training of Quality Systems.
Requirements:
  • HTL, Bachelor, or Master Degree or equivalent in a relevant field, such as Biotechnology, Bioengineering, Chemistry, Molecular Biology, or Biology.
  • At least 3-5 years of experience within QA/GMP regulated environment, preferably at a manufacturing site in the Biotechnology/Pharmaceutical Industry.
  • Good knowledge of GMP regulatory framework and regulatory bodies.
  • Experience with cold chain distribution.
  • Experience working with third Party Logistics Providers.
  • Excellent communication skills and ability to work cross-functionally, 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.
  • Proactive and solution-oriented in a fast-changing environment.
  • Detail-oriented, quick grasp of understanding.
Benefits:
  • 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.

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