Senior QA Specialist, GMP Biopharma Manufacturing

Gilead Sciences Inc.; Foster City (CA); On-site; USD 136,000 - 176,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Comprehensive benefits (medical, etc.)

Paid time off

Job summary

Gilead Sciences Inc. in Foster City, CA seeks a Sr. QA Specialist to ensure quality assurance objectives across manufacturing and analytical operations. You will support startup, readiness, and steady-state activities, aligning with manufacturing, QC, and development priorities.

The role is a site-based, individual-contributor position focused on ensuring GMP/GLP compliance and driving risk-based decision making to sustain product quality.

Qualifications

• 6+ years in a GMP-related environment with a BS/BA; or 4+ years with an MS.
• Hands-on experience supporting biologics, GMP Manufacturing and QC operations.

Responsibilities

• GMP Operations Quality Oversight.
• Review and approve investigations (OOS/OOT/deviations) with CAPA.
• Apply Quality Risk Management for risk assessments with Manufacturing and QC.
• Assist in controlled document changes to meet quality objectives.
• Maintain GMP/GLP programs and ensure compliance.
• Review data from manufacturing, environmental monitoring and QC.
• Collaborate with cross-functional teams on audits and inspections.

Skills

QA Principles

GMP/GLP knowledge

Risk management

CAPA investigations

Leadership

Cross-functional collaboration

Communication

Education

BS or BA in related field

MS in related field

Tools

Microsoft Office

DMAIC

GMP/GLP tools

Job description

Gilead Sciences Inc. in Foster City, CA seeks a Sr. QA Specialist to ensure quality assurance objectives across manufacturing and analytical operations. You will support startup, readiness, and steady-state activities, aligning with manufacturing, QC, and development priorities.

The role is a site-based, individual-contributor position focused on ensuring GMP/GLP compliance and driving risk-based decision making to sustain product quality.