Veterans Preferred - Senior Supplier Quality Specialist/Auditor
Company: Kite Pharma
Location: Santa Monica
Posted on: November 18, 2022
Military Veterans are Encouraged to Apply. -For Current Kite Pharma
Employees and Contractors:
Please log onto your Internal Career Site to apply for this
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
- Performs a wide variety of activities to ensure compliance with
applicable quality objectives and regulatory requirements.
- Develop, generate, evaluate and present process metrics reports
- Perform Supplier Quality Performance Monitoring/Surveillance
- 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
- 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
- Quality approver for change controls and specification
- Participates in health authority (e.g. FDA, EMA, TGA)
- Represents supplier quality on cross-functional teams for new
products, technologies, annual product reviews (APR), and
- 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
- Domestic and International travel up to 25%
- 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
- 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
- ASQ Certified Quality Auditor, Engineer, or Supplier Quality
Professional (CQA, CQE, or CSQP).
- Supplier quality management experience in a GMP
- 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
- Understanding of Validation principles applied in a supplier
- Demonstrates good verbal, written, and interpersonal
- Ability to manage competing priorities.
- Demonstrates proficiency in Microsoft Office applications.
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 email@example.com for
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
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
Keywords: Kite Pharma, Santa Monica , Veterans Preferred - Senior Supplier Quality Specialist/Auditor, Accounting, Auditing , Santa Monica, California
Didn't find what you're looking for? Search again!