Quality Manager

This position, with direction from QV management, is responsible for providing Quality & Compliance oversight to site validation projects related to Drug Substance and/or Drug Product Vaccine manufacturing.

Responsibilities/Skills:
   
  • Participate in project teams involved on site biotech facilities, processes and equipment for the manufacturer of Drug Substance and/or Drug Product Vaccines  
  • Review and approve validation related studies for assigned areas
  • Validation, Equipment and Facility Qualification and Validation Risk Management. 
  • Working knowledge of cGMPs and regulatory requirements 
  • Experience with validation of biotech manufacturing processes (i.e. viral antigen or formulation production) and knowledge of current FDA regulations and industry guidance related to validation processes 
  • Knowledge of vaccines/biologics products and associated technologies 
  • Ability to work on cross functional project teams  
  • Experience with Quality Systems including: SAP, Quality eDoc, LabWare, TrackWise and MS Office 
   
Education/Experience:

  •  5+ years experience in a GMP regulated environment working on validation projects associated with biotech processes and equipment. 
  • Strong Commissioning and Qualification background

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