Sr. Quality Assurance Specialist
$136340/y-$176440/y
Gilead Sciences2 days ago
Highlight
OnsiteFull-timeSenior
Summary
Gilead Sciences is seeking a highly motivated and experienced Sr. Quality Assurance Specialist to join the Corporate Engineering and Facilities (CEF) team in Foster City, CA. The role involves providing quality oversight and hands-on ownership for GxP quality records associated with facilities, utilities, equipment, instruments, and engineering systems.
About the Role
As a Sr. Quality Assurance Specialist, you will ensure compliance with quality objectives, regulatory requirements, and current Good Manufacturing Practices (cGMP). You will manage deviation investigations, corrective and preventive actions (CAPAs), and change controls, ensuring records are complete, accurate, and inspection-ready. You will collaborate with various teams to align on investigations and corrective actions, develop quality system metrics, and support regulatory inspections.
About You
Required:
- Bachelor’s degree in a technical or scientific discipline with 6+ years of direct experience in the pharmaceutical or life-science industry, OR
- Master’s degree with 4+ years of direct industry experience.
- Strong proficiency in cGMPs and Quality Assurance system principles.
- Solid working knowledge of biotech/pharmaceutical facilities and utilities in regulated GxP environments.
Preferred:
- Demonstrated technical writing experience in biotech or pharmaceutical environments.
- Experience using GxP electronic systems, including EDMS, CMMS, and QMS platforms.
Benefits
- Competitive salary range of $136k–$176k.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off and comprehensive benefits package including medical, dental, vision, and life insurance.
Gilead Sciences
At Gilead, we set – and achieve – bold ambitions to create a healthier world for all people. From our pioneering virology medicines to our growing impact in oncology, we're delivering innovations once thought impossible in medicine. Our focus goes beyond medicines, and we also strive to remedy health inequities and break down barriers to care. We empower our people to tackle these challenges, and we’re all united in our commitment to help millions of people live healthier lives. Social Media Guidelines: https://www.gilead.com/social-media-guidelines
San Francisco Bay Area