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Quality Assurance Lead

2 months ago

Bethesda Maryland, United States Valneva Full time

About Valneva

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.


We have leveraged our expertise and capabilities both 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.


We are a global company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.


Responsibilities

  • Work as primary 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 products at external partners from a QA perspective
  • Perform review, QA approval and administration of external documents (e.g. Reports, Deviations, 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 (e.g. handling of external non-conformance records, documents and Change Controls)
  • Interact with QP's as well as other internal stakeholders regarding Quality Oversight of Third-Party Logistics Partners operations for marketed products
  • Tracking and reporting of key performance indicators
  • Participate in compilation of Product Quality Reviews
  • Contribute to the continuous improvement of the quality assurance management system for all aspects of the activities of Valneva, 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 & 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 3-5 years of experience within QA/ GMP regulated environment, preferably at a manufacturing site in Biotechnology / Pharmaceutical Industry
  • Good knowledge of GMP regulatory framework and regulatory bodies
  • Experience working with third Party Logistics Providers
  • 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
  • Proactive and solution-oriented in a fast-changing environment
  • Detail oriented, quick grasp of understanding