Gilead Sciences · 4 hours ago
Sr Specialist, Quality Systems
La Verne, CA
Full-time
Onsite
Mid, Senior Level
$124K/yr - $160K/yr
4+ years expGilead Sciences is dedicated to creating a healthier world by developing therapies for serious diseases. The Senior Quality Assurance Specialist will oversee quality records and collaborate with teams to ensure compliance with regulatory standards and continuous improvement in quality practices.
BiopharmaBiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements
Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed, to ensure defined quality objectives are met
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs)
Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products
Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis, to enforce requirements and meet specifications
May participate in the writing contribution of annual product reviews and the development of training programs regarding all aspects of producing quality products
May conduct or serve as a lead/coordinator/reviewer/approver for investigations, change controls, and corrective and preventive action (CAPA) recommendations related to manufactured products
Works with Research and Development during new product start-ups and establishes key checkpoints for new products and processes
May assist or lead compliance audits as required. May interface with regulatory agencies as required
Interfaces with contract manufacturers to address documentation and compliance issues
Mentor QA personnel, including organizing and prioritizing daily tasks, and performing training
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)
Qualification
Required
Doctorate OR
Master's and 4+ years of relevant experience OR
Bachelor's and 6+ years of relevant experience
Preferred
Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs)
Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards
Advanced understanding of international quality systems regulations to adopt best in class systems/processes
Demonstrates the ability to effectively manage multiple projects/priorities
Strong proficiency in QA systems and continuous improvement methodologies
Proficient in QA principles, industry standards, and regulatory requirements
Strong knowledge of GMPs and/or GLPs
Ability to manage multiple projects and priorities effectively
Strong analytical, conceptual, and problem-solving skills
Excellent verbal communication, technical writing, and interpersonal skills
Proficiency in Microsoft Office applications
Familiarity with Six Sigma, DMAIC methodology, and quality improvement tools (preferred)
Working knowledge of risk management tools such as HACCP and FMEA (preferred)
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
2026-01-09
2026-01-08
2026-01-07
Company data provided by crunchbase