Senior Associate Scientist, External Quality Analytical Oversight

Key Responsibilities

The Senior Associate Scientist in External Quality Analytical Oversight role supports external commercial QC through hands-on execution of activities and processes related to data review, documentation, method lifecycle support, and continuous improvement. Working within established procedures and with guidance from senior colleagues, the role helps ensure accurate, timely, and compliant QC deliverables.

Focus Areas

• Perform review of external QC laboratory data for commercial release and stability testing, including contract testing laboratory (CTL) Certificates of Analysis (CoA), stability reports, and supporting documentation, in accordance with Gilead procedures for oversight of contract laboratory data.
• Perform data-based review of CTL raw data packages, including verification of 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 lab information management system (LIMS) to verify accurate 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 electronic documentation management system to retrieve, review, and accept CTL CoAs, stability reports, raw data packages, specifications, and test methods; maintain document metadata and workflows and document data review findings and discrepancies.
• Partner with QC Leads, CTLs, and QA to resolve data discrepancies, request and track CTL corrections, and ensure data review is completed within required turnaround times.
• Identify, document, and escalate data review findings, including atypical results, trends, and data integrity or ALCOA++ concerns; support related laboratory investigations (OOS/OOT/OOE), 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.

Experience

• Experience with Commercial Quality Control, analytical development, or a related laboratory environment.
• Working knowledge of GMP principles, data integrity expectation of lab data, and applicable procedures and standards in the US and internationally.
• Must be able to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• Demonstrated ability to manage and influence Quality Control testing at contract laboratory facilities and ensure alignment with Gilead's GMP policies.
• Demonstrated the ability to influence process and outcomes across functions.

Requirements

• BS degree in Chemistry, Biochemistry or related field with 5+ years of relevant experience OR MS degree in Chemistry, Biochemistry or related field with 3+ years of relevant experience
• Knowledge and experience in commercial quality control.
• Stays ahead of shifting trends in industry.
• 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.