Global Director, Analytical Quality Assurance

Gilead Sciences Inc.; United States; Remote; USD 191,000 - 272,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Medical, dental, vision insurance

Job summary

Gilead Sciences Inc. is seeking a senior Analytical Quality Assurance leader to oversee external QC testing labs, stability programs, and method validation within a GMP-regulated environment.

You will guide the Analytical Quality Assurance team, partner with Manufacturing and contract labs, review quality documents, and ensure regulatory readiness across NDA filings. This role emphasizes risk-based decision making, audits, CAPA management, and continuous improvement in a global setting.

Qualifications

• Experience in pharmaceutical quality, analytical sciences, Quality Control, Quality Assurance, or GMP-regulated environments with progressive leadership responsibilities.
• Strong ability to lead and develop high-performing teams while driving accountability and continuous improvement.

Responsibilities

• Lead analytical quality oversight for external QC testing laboratories, stability programs, analytical methods, and related GMP analytical operations.
• Provide quality governance for contract partners and testing laboratories, partnering with Manufacturing and external partners to support product lifecycle and regulatory priorities.
• Review and audit analytical data and CMC sections of NDA and global regulatory filings, as applicable.

Skills

Quality oversight

Regulatory compliance

Leadership

Cross-functional collaboration

Education

Bachelor's degree in chemistry, biology or related field

MS in chemistry, biology, or related field

PhD in chemistry, microbiology, or related field

Tools

Audit management software

Document management systems

Job description

Gilead Sciences Inc. is seeking a senior Analytical Quality Assurance leader to oversee external QC testing labs, stability programs, and method validation within a GMP-regulated environment.

You will guide the Analytical Quality Assurance team, partner with Manufacturing and contract labs, review quality documents, and ensure regulatory readiness across NDA filings. This role emphasizes risk-based decision making, audits, CAPA management, and continuous improvement in a global setting.