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Associate Director, Supplier Quality Management - United States  

Kite Pharma (company)


Posted on : 01 June 2017

Project 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.
  • We are seeking a highly motivated individual to join us as an Associate Director, Supplier Quality Management (SQM).  
  • You will work with the Quality team in supporting our efforts in this exciting new area of cancer immunotherapy.  
  • This individual will work cross functionally to execute and improve the SQM program for contract test labs (CTL) and testing material specifications (TMS).


Responsibilities (include but are not limited to):
Responsible for Contract Test Labs (CTL) and Testing Materials Specifications (TMS) in Supplier Quality Management:
  • Accountable for the GMP compliance of: audits, QTAs, SCARs, management of supplier initiated changes. 
  • Manage cross-functionally within the company  and externally to assure compliance and strong relationships with the labs and suppliers. 
  • Collaborate within SQM team to improve:  
    • supplier qualification and specification development processes that will use risk-based tools for qualification, classification and monitoring. 
    • supplier QTA process and assure a process to assure key quality expectations are reflected in supplier’s operations and updates for changes are managed. 
    • Supplier initiated change notifications 
    • phase-appropriate material and supplier requirements to meet Phase 2 and PPQ timelines   
  • Assure audit schedule and approved supplier list (Oracle Agile and EBS) are maintained. 
  • Monitor and report on meaningful performance metrics 
  • Provide leadership and direction for lab-related and TMS issues - SCARs, CAPAs, OOS. 
  • Lead, develop and manage staff. 
  • Support inspection readiness plans and interact with regulatory agencies during inspections on SQM-related matters, as needed. 
  • Ability to travel up to 25% 
  • Perform other duties as assigned. 

  • Bachelor’s degree in biological sciences or related field with minimum of 10 years’ experience in a pharmaceutical or biologics supplier quality management role; biologics or vaccines experience preferred 
  • Previous experience managing and developing staff with a minimum of 8 years of experience. 
  • Experience auditing CTLs, testing materials/raw materials, sterilization facilities. 
  • Experience with direct FDA interaction (or other regulatory agencies) required 
  • ASQ Certified Quality Auditor preferred 
  • Experience writing, evaluating and closing investigations, CAPAs and change control records. 
  • In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards 
  • Willingness to think outside of the box and adapt best practices to this small, but growing environment 
  • Proficient in MS Word, Excel, and Power Point 
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment 
  • Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies 
  • Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities 
  • Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description. 

About Us:
  • Our company is an equal opportunity employer.
  • We are able to offer the opportunity to be part 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.