Kite Pharma · 4 hours ago
QA Specialist III
Santa Monica, CA
Full-time
Onsite
Mid Level
$107K/yr - $139K/yr
3+ years expKite Pharma is a biopharmaceutical company focused on developing innovative cancer immunotherapies. The QA Specialist III will provide quality oversight for contracted service providers and ensure compliance with regulatory standards while collaborating with various teams within the organization.
BiotechnologyHealth CareMedicalOncologyTherapeutics
Responsibilities
Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities
Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements
Compilation of critical material and product disposition packages. Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply
Perform disposition (release) of product from CMOs
Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs
Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks
Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations
Up to 10% travel (domestic)
Qualification
Required
Master's Degree and 3+ years' experience in GMP environment related field OR
Bachelor's Degree and 5+ years' experience in GMP environment related field
Quality support of one or more CMO/CDMO and execution of all day-to-day quality operational responsibilities
Authoring, review and/or approval of GxP records and documents (both internal and external) including but not limited to: master and executed production batch records, investigations, corrective actions, change controls, protocols and reports, annual product quality reviews, IND/BLA/MAA CMC modules, Quality Agreements
Compilation of critical material and product disposition packages
Project management of disposition deliverables (e.g. investigations, batch records) ensuring timely critical material and/or product supply
Perform disposition (release) of product from CMOs
Ownership of critical issues or risks that emerge and provide mitigation recommendations to the team; monitoring performance related to performance of Kite's CMOs
Assist, gather and analyze information to support External Supply Quarterly Management Review, provide mitigation plans for issues and risks
Supporting agency inspections as quality focused topic subject matter expert for all inquiries relating to external operations
Up to 10% travel (domestic)
Preferred
Working with or at contract manufacturing or testing organizations or supporting partnerships
Diplomacy skills and ability to assess performance and proactively identify and mitigate risks
Experience with collaborating in a cross-functional working model with support from fully-and partially dedicated resources; ability to manage through influence
Experience with direct FDA interaction (or other regulatory agencies)
Experience writing, evaluating and closing investigations, CAPAs and change control records
Must be able to work on multiple projects simultaneously and demonstrate organizational, prioritization, and time management proficiencies
Excellent oral and written communication skills
Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description
Previous experience in Quality Control, Quality Assurance or Analytical Science
Benefits
Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
Company
Kite Pharma
Kite Pharma is a biotechnology company that designs and develops immune-based therapies to treat cancer indications.
1001-5000 employees
H1B Sponsorship
Kite Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (54)
2024 (47)
2023 (54)
2022 (59)
2021 (53)
2020 (38)
Funding
Current Stage
Public CompanyTotal Funding
$335.38MKey Investors
Alta Partners
2017-08-28Acquired
2015-12-10Post Ipo Equity· $250.12M
2014-06-20IPO
Leadership Team
Craig Vermeyen
Director, Packaging and Labeling
Mark Jurgens
Executive Director, Head of External Scientific Collaboration
Recent News
BioWorld Financial Watch
2025-12-29
2025-12-07
Company data provided by crunchbase