Senior Associate Scientist, External Quality Analytical Oversight

Gilead Sciences•Foster City, CA

11d•$117,895 - $152,570•Onsite

About The Position

The Senior Associate Scientist, External Quality Analytical Oversight supports external commercial Quality Control across Gilead’s commercial manufacturing network, helping ensure global cGMP compliance. The position performs hands-on activities involving external laboratory data review, documentation, analytical method lifecycle support, and continuous improvement. Working within established procedures and with guidance from senior colleagues, the role helps deliver accurate, timely, and compliant QC work and collaborates with QC Leads, contract testing laboratories (CTLs), and Quality Assurance.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, or a related field and at least 5 years of relevant experience, or a master’s degree in one of these fields and at least 3 years of relevant experience.
Experience in Commercial Quality Control, analytical development, or a related laboratory environment.
Knowledge and experience in commercial Quality Control.
Working knowledge of GMP principles, laboratory data integrity expectations, and applicable procedures and standards in the United States and internationally.
Ability to develop and improve complex concepts, techniques, standards, and 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 GMP policies.
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.
Ability to stay ahead of shifting industry trends.

Responsibilities

Review external QC laboratory data for commercial release and stability testing, including CTL Certificates of Analysis, stability reports, and supporting documentation, in accordance with Gilead procedures.
Review CTL raw data packages, including method conditions, sample and standard preparation, reference standard use, system suitability, representative chromatograms, and calculation accuracy; support assigned Level 3 on-site data reviews.
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 document data review findings and discrepancies.
Partner with QC Leads, CTLs, and QA to resolve data discrepancies, request and track corrections, and complete data reviews within required turnaround times.
Identify, document, and escalate data review findings, including atypical results, trends, and data integrity or ALCOA++ concerns; support 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; author or revise SOPs, work instructions, and job aids, and support system changes and user testing.