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Veterans Preferred - Senior Supplier Quality Specialist/Auditor

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

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. 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 seeking a Senior Supplier Quality Specialist as part of the Corporate Supplier Quality Management team at our site in Santa Monica, CA. In this role, you will work with suppliers and internal stakeholders throughout the supplier and product lifecycle. This includes supplier qualification and monitoring activities, managing supplier-initiated changes, and supporting supplier discontinuation.

Responsibilities:

  • Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • Develop, generate, evaluate and present process metrics reports and dashboards.
  • Perform Supplier Quality Performance Monitoring/Surveillance assessments.
  • Support the selection of GxP suppliers with Sourcing through due diligence activities and product quality team assessments.
  • Evaluates supplier qualification requests from cross-functional partners and initiates supplier qualification evaluations.
  • Evaluates suppliers for qualification using a risk-based approach through questionnaires and audits.
  • Negotiates, executes and maintains quality agreements with suppliers.
  • Conducts/reviews root cause investigations, corrective actions, and effectiveness as applied to Deviations and SCARs.
  • Receives, evaluates, and processes supplier notification changes (SNAs); ensuring impact assessments are assigned to and completed by the appropriate subject matter experts (SME). May also perform impact assessments as the Supplier Quality SME.
  • Discontinues or disqualifies GxP suppliers based on quality and business needs.
  • Quality approver for change controls and specification review.
  • Participates in health authority (e.g. FDA, EMA, TGA) inspections.
  • Represents supplier quality on cross-functional teams for new products, technologies, annual product reviews (APR), and sites.
  • Manages training curriculums for SQM team.
  • Communicate supplier Quality risks to upper management while suggesting improvements and cost savings where possible
  • Support site Quality Management Review for supplier quality.
  • Domestic and International travel up to 25%

    Basic Qualifications
    • Master's Degree, auditing experience and 5+ years of experience in a GMP environment OR
    • Bachelor's Degree, auditing experience and 7+ years of experience in GMP environment OR
    • High School Degree, auditing experience and 11+ years of experience in GMP environment

      Preferred Qualifications
      • Degree in a life science (Engineering or Science)
      • Prior experience in a pharmaceutical, gene and cellular therapy, or medical device industry.
      • External supplier auditing and/or Quality Compliance GMP auditing experience
      • ASQ Certified Quality Auditor, Engineer, or Supplier Quality Professional (CQA, CQE, or CSQP).
      • Supplier quality management experience in a GMP environment.
      • Demonstrates working knowledge of International and Domestic Regulations (ex. FDA, TGA, etc.)
      • Demonstrated ability to apply statistical quality engineering tools in a supplier environment.
      • Understanding of risk management principles
      • Prior experience developing supplier related metrics.
      • Ability to conduct/review root cause investigations, corrective actions, and effectiveness as applied to Deviations and SCAR's.
      • Understanding of Validation principles applied in a supplier manufacturing facility.
      • Demonstrates good verbal, written, and interpersonal communication skills.
      • Ability to manage competing priorities.
      • Demonstrates proficiency in Microsoft Office applications.

        #QCQA123

        #IND123

        #LI-ML1

        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 - Senior Supplier Quality Specialist/Auditor, Accounting, Auditing , Santa Monica, California

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