Director of Product Quality & Strategy

Gilead Sciences Inc.; Foster City (CA); On-site; USD 210,000 - 272,000; Full time

Benefits offered by this job

Discretionary annual bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. is seeking a senior Quality leader in Foster City, CA to drive product quality strategy across development, manufacturing, and regulatory teams. The role emphasizes risk-based assessments, lifecycle management, and ensuring regulatory readiness.

The ideal candidate has 12+ years in quality leadership in regulated settings, with experience in regulatory submissions (IND/NDA/BLA) and inspections. This position offers competitive compensation and comprehensive benefits.

Qualifications

• 12+ years of quality leadership in regulated environments.
• Experience with regulatory submissions (IND, NDA, BLA, MAA) and inspections.
• Strong cross-functional leadership across development, manufacturing, analytics, and regulatory.
• Experience with product quality lifecycle, control strategies, and lifecycle management.

Responsibilities

• Lead Product Quality Team activities to align on PQT priorities and deliverables across the product lifecycle.
• Evaluate process and product quality data using science- and risk-based methods.
• Develop control strategies for in-process control, starting material, drug substance and drug product specifications.
• Review and support regulatory filings and health authority responses.
• Ensure inspection readiness and provide cross-functional guidance to stakeholders.
• Communicate complex quality information clearly to leadership and regulators.

Skills

Quality leadership

Cross-functional collaboration

Regulatory knowledge

cGMP expertise

Risk-based decision making

Communication skills

Data interpretation

Project management

Education

Bachelor’s degree in science

MS/PhD in related field

Job description

Gilead Sciences Inc. is seeking a senior Quality leader in Foster City, CA to drive product quality strategy across development, manufacturing, and regulatory teams. The role emphasizes risk-based assessments, lifecycle management, and ensuring regulatory readiness.

The ideal candidate has 12+ years in quality leadership in regulated settings, with experience in regulatory submissions (IND/NDA/BLA) and inspections. This position offers competitive compensation and comprehensive benefits.