The Head of Quality Control is responsible for designing and implementing innovative and robust processes for testing activities associated with a viral gene therapy manufacturing site which includes bulk product and sterile fill operations. Location- Durham, NC #LI- onsite About the Role Key Responsibilities: Develops and executes corporate quality policies, practices, procedures, standards, and systems necessary to ensure adherence to aseptic production and product management in accordance with the cGXP compliance to US and EU regulations. Oversees the testing and validation strategy, with a concentrated focus on method verification and validation. Maintains a robust Environmental Monitoring program that meets US/EU and other applicable regulatory requirements. Organizes and directs cross-functional relationships with Manufacturing, Engineering, MS&T, Quality Assurance, and Regulatory. Hires staff and manages contract vendors for programs related to focus area. Directs laboratory staff, sets goals and expectations, and maintains efficient utilization of resources. Authors and approves documents required for regulatory submissions. Develops, implements, and ensures laboratory procedures and policies are followed. Provides presentations, explains laboratory qualification and operations, and defends testing results during FDA and other inspections. Other duties for which QC is responsible, as assigned. Requirements: BS/MS in Microbiology discipline and 12 years of related experience in cGMP laboratory environment, with strong knowledge of regulatory, USP and Eur. Phr guidelines (Ph.D. in life sciences is preferred). 8 years of laboratory management experience. Experience starting up lab facilities supporting clinical and/or commercial manufacturing. Experience with regulatory agency inspections. #J-18808-Ljbffr Novartis Farmacéutica
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