Senior QC Data Integrity Scientist - External Oversight

Gilead Sciences Inc.; Foster City (CA); On-site; USD 118,000 - 153,000; Full time

Benefits offered by this job

Discretionary bonus

Stock-based incentives

Paid time off

Benefits package

Job summary

Gilead Sciences Inc. in Foster City, CA seeks a Senior Associate Scientist to support external QC across the commercial manufacturing network, ensuring cGMP compliance.

You will collaborate with cross-functional teams to maintain data integrity and timely delivery of QC documentation. You will perform data reviews, drive continuous improvement, and help resolve discrepancies, audits and regulatory commitments while working on site up to five days a week.

Qualifications

• Experience in Commercial Quality Control or analytical development.
• Knowledge of GMP and data integrity in US and international contexts.
• Ability to develop and improve complex concepts and standards.
• Experience coordinating with contract laboratories and QA.

Responsibilities

• Review external QC data for commercial release and stability testing.
• Verify CTL raw data packages against specifications and prepare CoAs.
• Use LIMS to verify transcription of results and generate provisional CoAs and reports.
• Review audit trails and maintain documentation metadata and workflows.
• Collaborate with QC Leads, CTLs and QA to resolve data discrepancies and ensure timelines.
• Identify data integrity concerns; support investigations and CAPAs.
• Compile QC metrics and track release timelines and outstanding issues.
• Coordinate SAP specification authoring and updates with QC stakeholders.

Skills

Quality Control

GMP

Analytical thinking

Data review

Documentation

Communication

Education

BS in Chemistry/Biochemistry

MS in Chemistry/Biochemistry

Tools

LIMS

SAP

Job description

Gilead Sciences Inc. in Foster City, CA seeks a Senior Associate Scientist to support external QC across the commercial manufacturing network, ensuring cGMP compliance.

You will collaborate with cross-functional teams to maintain data integrity and timely delivery of QC documentation. You will perform data reviews, drive continuous improvement, and help resolve discrepancies, audits and regulatory commitments while working on site up to five days a week.