Senior Associate Scientist, External Quality Analytical Oversight

Gilead Sciences • Foster City, CA

9d • Onsite

About The Position

The Senior Associate Scientist, External Quality Analytical Oversight supports external commercial QC across Gilead’s manufacturing network, helping ensure global cGMP compliance and timely, accurate, compliant QC deliverables. The role performs hands-on activities involving data review, documentation, analytical method lifecycle support, and continuous improvement, working within established procedures and with guidance from senior colleagues. This is a site-based position in Foster City, California, up to five days per week.

The position reviews external QC laboratory data for commercial release and stability testing, verifies CTL raw data packages, and uses LIMS and electronic documentation systems to review, authorize, and document results and records. The Senior Associate Scientist partners with QC Leads, contract testing laboratories, and QA to resolve discrepancies, escalate findings, support investigations and CAPAs, track review and release status, coordinate SAP specification updates, and improve data-review processes and electronic workflows.

Requirements

• BS degree in Chemistry, Biochemistry, or a related field with 5+ years of relevant experience, or an MS degree in Chemistry, Biochemistry, or a related field with 3+ years of relevant experience.
• Knowledge and experience in commercial quality control.
• Experience in Commercial Quality Control, analytical development, or a related laboratory environment.
• Working knowledge of GMP principles, laboratory data-integrity expectations, and applicable procedures and standards in the US and internationally.
• Ability to develop and improve complex concepts, techniques, and standards, and develop new applications based on quality principles and theories.
• Demonstrated ability to manage and influence QC testing at contract laboratory facilities and ensure alignment with Gilead’s GMP policies.
• Demonstrated ability to influence processes and outcomes across functions.
• Ability to think critically, analyze information, and work independently on defined assignments while seeking guidance when needed.
• Strong organizational, planning, and attention-to-detail skills.
• Effective verbal and written communication skills and a collaborative working style.

Nice To Haves

• Stays ahead of shifting trends in the industry.

Responsibilities

• Review external QC laboratory data for commercial release and stability testing, including contract testing laboratory Certificates of Analysis, stability reports, and supporting documentation, according to Gilead procedures.
• Review CTL raw data packages, verifying method conditions, sample and standard preparation, reference standard use, system suitability, representative chromatograms, and calculation accuracy; support Level 3 on-site data reviews as assigned.
• Use LIMS to verify transcription of results against CTL documents and specifications; complete test- and sample-level review and authorization, review audit trails, and generate provisional CoAs, Stability Summary Reports, and Analytical Reports.
• Use the electronic documentation management system to retrieve, review, and accept CTL documents; maintain document metadata and workflows and record data-review findings and discrepancies.
• Partner with QC Leads, CTLs, and QA to resolve data discrepancies, request and track CTL corrections, and complete reviews within required turnaround times.
• Identify, document, and escalate data-review findings, including atypical results, trends, and data-integrity or ALCOA++ concerns.
• Support laboratory investigations, including OOS/OOT/OOE investigations, deviations, and CAPAs.
• Compile and report QC data-related metrics; maintain review and batch-release trackers; and communicate status, turnaround times, and outstanding issues.
• Coordinate SAP specification authoring and updates with designated authors and QC stakeholders, tracking completion and confirming alignment with approved specifications.
• Contribute to continuous improvement of data-review processes and electronic-system workflows, including authoring or revising SOPs, work instructions, and job aids, and supporting system changes and user testing.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives, subject to role eligibility.
• Paid time off.
• Company-sponsored medical insurance.
• Company-sponsored dental insurance.
• Company-sponsored vision insurance.
• Company-sponsored life insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior