QC Strategy Lead, Small Molecules

Gilead Sciences Inc.; Foster City (CA); On-site; USD 182,000 - 236,000; Full time

Job summary

Gilead Sciences Inc. in Foster City, CA seeks a Principal Scientist to lead External Quality Analytical Oversight for small molecules, ensuring cGMP compliance and data integrity.

You will provide strategic QC oversight across methods, specifications, and regulatory submissions, partnering with cross-functional teams and managing external testing laboratories to deliver compliant results for commercial programs.

Qualifications

• 10+ years’ experience with a BS OR 8+ years MS OR 5+ years PhD in a related field.
• Significant knowledge and hands-on leadership experience in small molecules and quality control.
• Experience with small molecule products and authoring CMC sections of regulatory submissions.
• Demonstrated experience managing testing activities at external testing laboratories.

Responsibilities

• Define, implement, and improve QC strategy for commercial small molecule programs.
• Oversee method validation, transfer, reference materials, and cGMP release testing.
• Coordinate testing at external contract labs to ensure on-time delivery.
• Draft and review CMC sections and regulatory submission support.
• Identify QC risks and drive corrective actions and CAPAs.

Skills

Leadership

QC Strategy

Data integrity

Cross-functional

Analytical testing

Education

PhD in a related field

MS in a related field

BS in a related field

Job description

Gilead Sciences Inc. in Foster City, CA seeks a Principal Scientist to lead External Quality Analytical Oversight for small molecules, ensuring cGMP compliance and data integrity.

You will provide strategic QC oversight across methods, specifications, and regulatory submissions, partnering with cross-functional teams and managing external testing laboratories to deliver compliant results for commercial programs.