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Manager, GxP Training - United States  

Company managed [?] Still accepting applications

Posted on : 03 July 2017

Project Description

About Us:
  • 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. 
  • We are seeking a highly motivated individual to join us as a Manager, GxP Training. 
  •  You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.  
  • This individual will be responsible for establishing and managing all aspets of a comprehensive and robust GxP Training Program.  
  • You will work cross functionally to develop and implement a training program that addresses the critical role training has in our company's rapid expansion to commercial manufacturing and first marketed product.  This role will be a hands-on resource reporting to the Director, GMP Training.


Responsibilities:
  • Support and enhance the standardized competency-based GxP training program for OJT in collaboration with Quality, Manufacturing and functional leads. 
  • Maintain the GxP onboarding process and deliver New Employee Orientation for all new employees. 
  • Enhance content and deliver annual GMP Training for incumbent staff. 
  • Collaborate with commercial and clinical Quality and Manufacturing managers to deliver and enhance the Trainer Development program for departmental SME/trainers. 
  • Develop and implement criteria to assess training effectiveness. 
  • Conduct periodic audits of training records. 
  • Support inspection readiness plans and interact with regulatory agencies during inspections on training related matters. 
  • Recruit, manage and develop team of training specialists to execute and improve company training programs, including development and delivery of training. 
  • Other duties as assigned 


Requirements:
  • Bachelor’s degree in biological sciences or education or related field; Master’s degree preferred 
  • Minimum of 5 years progressive GxP training experience in a pharmaceutical or biologics operation; biologics or vaccines experience preferred 
  • Management/leadership experience preferred. 
  • Strong working knowledge and ability to apply GMP in conformance to US, EU and ROW standards 
  • Proficient in MS Word, Excel and Power Point 
  • Previous experience presenting and responding to regulatory agency audits 
  • Demonstrated ability to develop, coach, and mentor employees 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Perform other duties as required 
 

About Us:
  • Our company is  an equal opportunity employer.
  • We are able to offer the opportunity to be part of this successful, fast growing company.
  • A place everyone knows your name and respects your opinion while at the same time offering benefits and time off packages commensurate to any large corporation.