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Quality Assurance Manager

Quality | Santa Monica, CA | Full Time

Job Description

Kite Pharma Inc, founded in 2009, is dedicated to the development and commercialization of novel cancer immunotherapy products designed to harness the power of a patient’s own immune system to fight tumor cells.  We are a dynamic and accomplished team with an exciting growth trajectory for the coming year.

The Quality Assurance (QA) Manager will provide QA oversight of clinical manufacturing of final drug product and identify and assess quality risk in activities and processes according to regulatory guidelines and standard operating procedures.  The successful candidate will be proficient in quality systems particularly lot dispositioning, change control and exception management/CAPA.  This position will report to the Director of QA and will be based in our headquarters in Santa Monica, CA.

Responsibilities (include but are not limited to):

  • Implement, manage, audit and maintain Kite Pharma’s quality systems to support clinical manufacturing
  • Work with the Contract Manufacturing Organization (CMO) as Kite Pharma’s Quality Assurance representative
  • Manage lot disposition activities and lot disposition standard lead times at the CMO, including:
    • Prepare, review, and approve lot disposition
    • Ensure timely assessment and closure of batch hold events
    • Communicate lot disposition pending issues to Management
    • Ensure Approval/Timely Delivery of Product
  • Ensure that products are manufactured in compliance with regulatory and GMP guidelines, specifically:
    • Review/Approve Manufacturing Documents and Validation Documents for Regulatory Compliance
    • Review Manufacturing Batch Records
  • Oversee quality investigations of manufacturing deviations, GMP issues, system issues, non-conforming materials, and CAPAs, including:
    • Provide QA support to resolving raw material, in-process material, bulk and final product, environmental, and manufacturing issues
    • Manage day-to-day activities for the initiation, tracking, and closure of non-conformances and CAPA activities
    • Provide periodic updates to Management of deviations, GMP issues, system issues, non-conforming materials, and CAPAs
  • Support regulatory inspections as well as internal and customer audits
  • Establish and manage supplier quality
  • Coordinate and perform vendor qualification and compliance audits
  • Review technical/ investigation reports as appropriate
  • Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
  • Provide QA guidance to product development projects and programs
  • Gather metric information for use in continuous improvement of areas of responsibility
  • Perform other duties as required
  • Perform other duties as assigned
  • Travel may be up to 25%

Requirements:

  • At least 8 years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).  Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10) with at least 3 years of experience in a management role
  • Bachelor’s degree in technical discipline (Chemistry/Microbiology/Engineering or similar)
  • Experience in the medical and/or pharmaceutical industry strongly preferred
  • ASQ, Black Belt/Green Belt certifications preferred
  • Experience with Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
  • Strong knowledge of GMP, SOPs and quality systems
  • Identifying, writing evaluating and closing CAPAs and experience with internal and external audit principals
  • Strong knowledge of aseptic manufacturing processes
  • Strong knowledge of change control practices/strategies
  • Equipment and utility IQ/OQ/PQ/PV
  • Proficient in MS Word, Excel, Power Point and other applications
  • Strong written and verbal communication skills, including the ability to communicate and work independently with scientific/technical personnel

Kite Pharma, an equal opportunity employer, is located in beautiful Santa Monica, CA just steps from Santa Monica Blvd and right off the 10.  We are able to offer the opportunity to be part of the first 100 employees in 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.   Did we forget to mention the stock options?   To learn more about us, please visit our website at www.kitepharma.com

If you are interested in applying for this opportunity, please submit your resume or CV, cover letter and salary requirements.  All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs.  If you are not contacted for an interview, your resume will remain on file and active for available positions for one year.

No phone calls please and no agencies or recruiters