Senior QA Leader: GMP Manufacturing & Compliance

Regulatory Jobs; Foster City (CA); On-site; USD 158,000 - 204,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Life insurance

Discretionary bonus

Stock-based long-term incentives

Job summary

Gilead Sciences Inc. in Foster City seeks a Sr. Manager, Quality Assurance to lead QA strategy and ensure cGMP compliance across manufacturing and QC operations from startup through steady-state production.

You will mentor Quality personnel, review investigations, approve GMP documentation, and partner with Manufacturing, Process Development, and Regulatory teams while maintaining Health Canada/FDA standards.

Qualifications

• 8+ years of experience in a GMP environment
• Hands-on experience supporting biologics, GMP Manufacturing and QC operations
• Strong cross-functional collaboration and communication skills
• Knowledge of QA principles and regulatory expectations

Responsibilities

• Provide QA strategy and oversight for GMP Manufacturing and QC operations.
• Review investigations (OOS/OOT/deviations) and ensure CAPA
• Approve GMP documentation and drive continuous improvement of quality processes
• Lead and mentor QA personnel supporting GMP operations
• Coordinate with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management

Skills

QA leadership

GMP knowledge

Regulatory compliance

Quality systems

Education

BS/BA in related field

MS in related field

GMP related certification

Job description

Gilead Sciences Inc. in Foster City seeks a Sr. Manager, Quality Assurance to lead QA strategy and ensure cGMP compliance across manufacturing and QC operations from startup through steady-state production.

You will mentor Quality personnel, review investigations, approve GMP documentation, and partner with Manufacturing, Process Development, and Regulatory teams while maintaining Health Canada/FDA standards.