Veterans Preferred - Quality Control Bioanalytical Lifecycle Manager

Company: Kite Pharma
Location: Santa Monica
Posted on: November 18, 2022

Job Description:

Military Veterans are Encouraged to Apply. -For Current Kite Pharma Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

Everyone at Kite is grounded by one common goal - curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work.

We are in search of a highly motivated individual to join us as a Quality Control Bioanalytical Lifecycle Manager, located at our Santa Monica, California or Frederick, Maryland location. This role will support the Global QC function reporting to the Head of Analytical Lifecycle Management (ALCM), but work cross functionally with Information Technology, site-based QC SMEs, and other departments within, and external to, Technical Operations. We are looking for a versatile and motivated individual who will drive Kite Laboratory Information Management System (KLIMS) implementation and execution of the Global QC long term strategy to deliver true value to the QC organization

Responsibilities (include, but are not limited to):

• Drive change management and business transformation efforts across the Global QC network
• Manage global QC initiatives in accordance with Good Manufacturing Practices (GMP) environment and creation and revision of Standard Operating Procedures (SOPs)
• Assist in the internal and external audit process, as well as inspection management process
• Act as a communication conduit between global and site-based functions related to program/project execution and resource requirements
• Support strategic planning, scoping, budgeting, and development of ALCM and KLIMS short/long term roadmaps
• Provide technical insight, management, and enhancement of Analytical Portfolio and LCM and global KLIMS working, reporting, and governance structure/interactions
• Lead Analytical Portfolio and LCM and KLIMS blueprinting and design sessions to gather QC functional requirements and translate them to technical requirements
• Prepare and disseminate QC Network communications
• Improve processes to minimize complexities and optimize operational effectiveness
• Interact with the laboratory operations group to support new methods, technology, and KLIMS implementation and ongoing support for new module implementations and/or installation of new capabilities
• Create and manage project plans, define project deliverables, assemble and facilitate working teams, identify and track issues and their resolution, and manage project requirements
• Highly effective written and oral communication skills to address a wide variety of audiences and governing bodies
• Demonstrated resilience, diplomacy, influence, relationship-building, and problem-solving skills in a variety of situations
  
  Basic Qualifications:
  
  • Master's Degree and 4+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR
  • Bachelor's Degree and 6+ years' experience in a Quality function in the pharmaceutical or biotechnology industry OR
  • High School Degree and 10+ years' experience in a Quality function in the pharmaceutical or biotechnology industry
    
    Preferred Qualifications:
    
    • Advanced business and/or science degree
    • Experience in a pharmaceutical or cell therapy setting
    • Experience with LabVantage LIMS or LIMS generally
    • Experience in areas such as sampling, pharmaceutical quality control lab, laboratory data and reports (C of C, C of A), data management, change control, GLP/GMP and compliance Ability to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
    • Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs.
    • General understanding of pharmaceutical GMPs and 21CFR Part 11 regulations
    • Comfortable in a fast-paced 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.
    • Experience in computer systems and risk management processes a plus
    • Experience with US and international health authority inspections a plus
    • Proficient in MS Word, Excel, Project and PowerPoint.
    • Availability to work extended hours to meet deadlines, when necessary
      
      #QCQA123
      
      #IND123
      
      Kite 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. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com . Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma .
      
      For jobs in the United States:
      
      As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability,genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.
      
      Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Kite has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
      
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      Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
      
      Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
      
      For Current Kite Pharma Employees and Contractors:
      
      Please log onto your Internal Career Site to apply for this job.

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