Sr. Quality Assurance Specialist

Responsibilities

• Provide quality oversight and ownership for GxP quality records associated with facilities, utilities, equipment, and engineering systems.
• Act as the primary Deviation Investigation Owner, conducting root cause analysis (RCA) and managing corrective and preventive actions (CAPAs).
• Author and manage Change Control records for facility modifications, equipment installations, and system updates.
• Develop, write, and implement controlled documents including SOPs, specifications, and work instructions.
• Support regulatory inspections and internal/external audits as a Subject Matter Expert (SME) for facilities and engineering.
• Facilitate cross-functional meetings with Engineering, EHS, Automation, and Validation teams to align on quality investigations.

Requirements

• Bachelor's degree in a technical or scientific discipline with 6+ years of experience in the pharmaceutical or life sciences industry, OR a Master's degree with 4+ years of experience.
• Proven experience working within a GMP-regulated environment.
• Strong proficiency in cGMP and Quality Assurance system principles.
• Expertise in Root Cause Analysis (RCA) and technical writing.
• Deep understanding of biotech/pharmaceutical facilities, utilities (HVAC, water systems, etc.), and instrumentation.

Preferred Qualifications

• Experience using GxP electronic systems, including EDMS, CMMS, and QMS platforms.
• Proficiency in Six Sigma/Lean tools and risk management methodologies such as HACCP or FMEA.
• Ability to read and interpret facility drawings, including P&IDs and floor plans.

About the Company

Gilead Sciences is a research-based biopharmaceutical company that has spent over 35 years tackling major diseases such as HIV, viral hepatitis, COVID-19, and cancer. We are dedicated to developing life-changing therapies and ensuring global access to improve the lives of patients everywhere.