Senior Supplier Quality Specialist Apply
Job Description
For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Kite, we empower our leaders to step up, share ideas, listen, learn, and lead. Were welcoming bright, diverse, and imaginative minds; were nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Job Description
Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies. We have two commercial products, Yescarta and Tecartus, along with an extensive pipeline of various autologous and allogeneic clinical programs.
We are seeking a Senior Supplier Quality Specialist at our site in Santa Monica, CA. In this role, you will support supplier qualification and supplier monitoring activities across Kites global network, with a focus on supporting supplier quality activities within the Pacific Region- Supplier Quality Management. You will also support cross functional teams and quality system processes as needed.
Responsibilities
- Performs a wide variety of activities to ensure compliance with applicable quality goals and regulatory requirements.
- Evaluates supplier qualification requests from cross-functional partners and initiates supplier qualification evaluations.
- Negotiates, implements and maintains quality agreements with suppliers.
- Evaluates suppliers for qualification using a risk-based approach through questionnaires and audits.
- Perform Supplier Quality Performance Monitoring/Surveillance assessments.
- Participates in Supplier Corrective Action Request (SCAR) process.
- Receives, evaluates impact, and processes supplier notifications and changes.
- Discontinues or disqualifies GxP suppliers based on quality and business needs.
- Support the selection of GxP suppliers with Sourcing through due diligence activities and product quality team assessments.
- Quality approver for quality events and reviews raw material specifications.
- Participates in health authority (e.g. FDA, EMA, TGA) inspections.
- Represents supplier quality on cross-functional teams for new products, technologies, and sites.
- Develop, generate, evaluate and present process metrics reports and dashboards.
- Support site Quality Management Review for supplier quality
Basic Qualifications
- Masters Degree, auditing experience and 4+ years of experience in GMP or similar OR
- Bachelors Degree, auditing experience and 6+ years of experience in GMP or similar OR
- High School Degree, auditing experience and 11+ years of experience in GMP or similar
Preferred Qualifications
- External supplier auditing experience and/or auditor certification (such as ASQ Certified Quality Auditor).
- Supplier quality management experience in a GMP environment.
- Demonstrates knowledge of Quality by Design, Quality Risk Management, and Product Lifecycle Management.
- Quality Compliance GMP auditing experience
- Prior experience in a pharmaceutical, gene and cellular therapy, or medical device industry.
- Degree in a life science.
- Demonstrates working knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Demonstrates knowledge of regulations (FDA/EMEA) and standards.
- Demonstrates basic knowledge of six sigma, LEAN, and root cause analysis instruments used for identifying and investigating deviations and establishing corrective and preventative actions.
- Demonstrates audit and investigation skills, including report writing skills.
- Demonstrates good verbal, written, and interpersonal communication skills.
- Demonstrates knowledge of particulate controls and sterility assurance (including aseptic manufacturing).
- Demonstrates proficiency in Microsoft Office applications.
Does this sound like you? If so, apply today
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The salary range for this position is: $121,125.00 - $156,750.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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.
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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 ApplicantAccommodations@gilead.com for assistance.
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For Current Kite Pharma Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
