Director of Quality

Company: FPC of Atlanta
Location: Apex
Posted on: November 22, 2021

Job Description:

Ready to build the biopharmaceutical Quality Operations processes and team that will oversee the development and manufacture of advanced biopharmaceutical products? Ready to learn what end to end capability can look like? Yes? Great! Read on and see what else will be involved with as Director of Quality Operations in the well-funded biopharmaceutical company.
Responsibilities include:

• Direct Quality activities supporting GMP manufacturing and testing activities.
• GMP Quality SME re documentation and compliance for facilities, equipment, methods and processes.
• Both Drug Substance and Drug Product responsibilities (at least initially)
• Oversee any outsourced testing activities for in-process, release and stability testing
• Help design and implement: EM program; Material testing program for manufacturing; Deviation, change controls, CAPA and overall site Quality Systems
• Author and review GMP SOPs, qualification protocols, specifications, test methods and reports.
• Train employees on GMP procedures and applicable regulatory regulations.
  Location: North Carolina Onsite or Remote: Onsite all or a significant % of time preferredRelocation eligible: Yes, lump sum assistance available
  Qualifications include:
  • B.S. or higher degree in Biological or other Life Science
  • 9+ year experience with biologics, biopharmaceuticals or sterile pharmaceuticals
  • 3+ years managerial experience strongly preferred
  • Strong leadership, training and motivational capabilities as well as the understanding of how important it is to develop people and create career paths for them.
  • Experience developing and implementing quality systems within the biologics or pharmaceutical industry.
  • Knowledge in all aspects of product development from investigational phase to commercial launch.
  • Ability and desire to build an organization and its capabilities
  • Experience in a rapidly growing GMP manufacturing environment
    
    
    

Keywords: FPC of Atlanta, Cary , Director of Quality, Executive , Apex, North Carolina