BrightOwl Loader Loading

Senior Manager, Quality Operations - United States  

Company managed [?] Still accepting applications

Posted on : 11 June 2017

Project Description

Description:
  • Our company  is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. 
  • The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors. 

 

Responsibilities (include but are not limited to):
  • Receipt and disposition of incoming materials. 
  • Review batch-related documentation, and ensures resolution of issues to release and ship product. 
  • Perform product disposition and lot closure. 
  • Oversee the packaging and shipping process; authorize shipment. 
  • Ensure all product-related Deviations are initiated, investigated and resolved.  
  • Ensures that associated CAPAs are initiated and resolved, as needed. 
  • Review and approve Change Control, as needed. 
  • Implement QA on the floor processes, including batch record review. 
  • Ensure process control measures are in place and followed in product manufacturing. 
  • Maintain metrics related to batch record review and product disposition in support of the Management Review and continuous improvement. 
  • Schedule staff to support manufacturing and packaging processes in order to ensure on-time delivery of product to patients. 
  • Train, manage, coach, and mentor staff. 
 


Requirements:
  • Bachelor’s degree in the biological sciences or related field. 
  • Minimum of 9 years progressive quality or manufacturing experience in a pharmaceutical, biotech,  or biologics operation 
  • Minimum of 4 years of management/leadership experience 
  • Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards 
  • Ability to effectively negotiate and build collaboration amongst individuals 
  • Demonstrated ability to train, manage, and coach staff 
  • Excellent interpersonal, verbal and written communication skills 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities