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Veterans Preferred - QA Sr Specialist II - Clinical Product Quality Lead

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. Join us in our mission!

We are seeking a QA Sr Specialist II, in the Product Quality Team for Kite's clinical products at our facility in Santa Monica, CA. The successful candidate will manage quality aspects of Kite's Early Phase Clinical Autologous and Allogeneic programs. The individual will provide technical expertise and assistance to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals.

As a product expert in Quality, this role has responsibility for technical expertise and project support for the Quality and Compliance aspects of the product throughout its life cycle. You will help to define the operational Quality strategy with the guidance of the Clinical Product Quality Associate Director and will be active in the execution of the strategies supporting the Clinical Operations Team.

The QA Sr Specialist II will work directly with Operations Leaders, International Expansion (IE), Quality Control (QC), corporate Quality, Regulatory, Process Development (PD), Quality Assurance (QA), etc. on the resolution of issues associated with process/manufacturing, in-process Control (IPC), analytical methods, specifications, reference standards, importation testing, investigations, change control, stability, regulatory submissions, international expansion and inspections related to product(s). Your work will driveinitiatives intended to ensure the overall product health.

Duties & Responsibilities:

  • Drive and execute product quality strategies through strong quality and scientific leadership related to technology transfers, global regulatory filing strategies, analytical method improvements, stability, product specifications and program improvements.
  • Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision making, performing a scientifically sound and risk-based evaluation of process and product quality data and developing patient-oriented strategies.
  • Support operationalizing theoretical concepts (e.g. product strategies) into actionable plans and execute those plans with successful outcomes.
  • Negotiate plans with regulatory authorities and internal multi-functional teams with guidance from the Associate Director, Clinical Product Quality, to obtain the optimal product quality position for life cycle management
  • Lead and actively participate in the Clinical Product Quality Team, and liaison with other teams as needed.
  • Author sections of regulatory submissions, as directed and support RTQs as applicable
  • Help develop the stability strategy of the Product
  • Support product quality data monitoring programs

    Basic Qualifications:

    PhD

    OR

    Master's Degree and 6+ years' experience in biotech / biopharma, technical operations

    OR

    Bachelor's Degree and 8+ years' experience in biotech / biopharma, technical operations

    OR

    High School Degree and 12+ years' experience in biotech / biopharma, technical operations

    Preferred Qualifications / Skills:
    • 5+ years working in a regulated environment (either direct GMP or technical support)
    • Excellent interpersonal, verbal and written communication skills, including facilitation and presentation skills, are essential in this collaborative work environment
    • Communicate complex ideas succinctly and clearly, both verbally and in writing, to a variety of audiences
    • Ability to influence others through persuasive interactions and garner support for novel solutions where applicable
    • Must be able to work on multiple projects simultaneously and demonstrate ability to organize, prioritize and manage time
    • Experience in Project Management in support of biopharmaceutical development
    • Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based upon changing priorities
    • Experience with authoring or review of biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation
    • Ability to work and navigate within an evolving scientific and regulatory environment.
    • Experience with authoring or review of biological license applications/MAAs, INDs/IMPDs, supplements/variations or similar regulatory documentation
    • Familiarity with compliance and regulatory requirements of the FDA as well as international regulatory agencies in international expansion regions
    • Knowledge of analytical techniques used for biologics product quality control with a preference for experience in analytical comparability assessments to support manufacturing changes
    • Experience in direct interaction with regulatory agencies/Boards of Health during inspections
    • Understanding of biologic product development and manufacturing principles
    • Knowledge of cGMP and filing regulations, guidelines, practices, and trends pertaining to the manufacture and testing of biopharmaceuticals
    • Previous experience working on a cross-functional team in a matrix environment

      #LI-ML1

      #QCQA123

      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.

      For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

      NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
      YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

      PAY TRANSPARENCY NONDISCRIMINATION PROVISION

      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.

Keywords: Kite Pharma, Santa Monica , Veterans Preferred - QA Sr Specialist II - Clinical Product Quality Lead, Healthcare , Santa Monica, California

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