Gilead Sciences · 7 hours ago
QA Specialist III
United States - California - Santa Monica
Full-time
Hybrid
Mid, Senior Level
$107K/yr - $139K/yr
3+ years expGilead Sciences, through its Kite Pharma division, is dedicated to curing cancer by developing innovative treatments. The QA Specialist III role involves providing quality oversight for contracted service providers and ensuring compliance with regulatory standards in the cell therapy space.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
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
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
Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops, manufactures and commercializes therapies for critical diseases.
10001+ employees
H1B Sponsorship
Gilead Sciences 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 (269)
2024 (241)
2023 (222)
2022 (208)
2021 (235)
2020 (187)
Funding
Current Stage
Public CompanyTotal Funding
$4.41BKey Investors
Abingworth
2024-11-13Post Ipo Debt· $3.5M
2024-02-29Post Ipo Equity· $210M
2023-09-07Post Ipo Debt· $2B
Leadership Team
Keeley Wettan
Senior Vice President, Legal
Patrick Loerch
Senior Vice President, Clinical Data Science
Recent News
2026-01-23
GlobeNewswire
2026-01-22
Company data provided by crunchbase