Sr Scientist, Quality Control Lead, Small Molecules

Description  The Sr Scientist, Quality Control (QC) Lead will be responsible for the strategic oversight and operational execution of cGMP analytical testing in support of small molecule clinical development programs. The role provides leadership for assigned programs across a range of QC activities, ensuring that testing, documentation, and data integrity standards meet regulatory requirements and project deliverables. The ideal candidate will bring technical expertise in analytical chemistry and cGMP operations, a strong understanding of phase-appropriate quality control strategies and requirements, and the ability to collaborate cross-functionally to enable successful delivery of clinical supply and development milestones. FOCUS AREASQuality Control Leadership & StrategyDefine, implement, and continuously improve the QC strategy for small molecule clinical development programs in alignment with overall CMC and quality objectives.Serve as the point of contact for overall QC activities including method validation and transfer, reference materials, specifications, cGMP release testing, stability strategy and testing, and supervision of testing at external contract testing laboratories.Develop and maintain phase-appropriate QC strategies and processes to support manufacturing and regulatory submissionsResponsible for the management and approval of specifications, collaborating cross-functionally to establish scientifically sound and phase-appropriate specifications aligned with analytical capability, process understanding, and clinical and regulatory expectationsRepresent QC on cross-functional product development teams, providing technical input and direction for analytical and quality decisions.Identify and drive opportunities for improvement in QC testing, workflows, data management, and compliance processes.Proactively identify and escalate potential QC risks, and communicate QC activities, risks, and issues to relevant stakeholdersAnalytical Testing & DocumentationOversee and ensure compliant execution of QC testing for raw materials, intermediates, drug substance, and drug productEnsure timely creation, review, and approval of QC documentation including test methods, protocols, reports, CoAs, and quality recordsProvide QC oversight to contract testing laboratories, coordinating testing activities for on-time delivery and confirming compliance with cGMP and data integrity expectationsDirect and oversee timely resolution of QC testing related investigations with comprehensive root-cause analysis, risk assessment, and effective CAPAsCompliance & Regulatory AffairsEnsure QC operations comply with cGMP, FDA, EMA, ICH, and other applicable regulations.Drive excellence in data integrity, documentation practices, and traceability across QC activitiesServe as a QC subject matter expert to draft and review CMC sections and supporting documents for regulatory filings and response to questions (RTQs).Cross-Functional CollaborationPartner closely with Analytical Development, Manufacturing, Quality Assurance, Regulatory, and Supply Chain to ensure seamless coordination of analytical strategy and QC testing support throughout the product lifecycleSupport technology transfer and method implementation at internal and external laboratoriesProvide QC input into product development and regulatory submission documentationBasic Qualifications:PhD or PharmD in a related field with 2+ years of experienceORMaster's Degree with 6+ years of experienceORBachelor's Degree with 8+ years of experienceORAssociate's Degree with 10+ years of experienceORHigh School Degree with 12+ years of experiencePreferred Qualifications: 8+ years of hands-on and leadership experience in small molecule pharmaceutical analytical testing and quality control.Prior experience establishing analytical specifications and authoring CMC sections of regulatory submissions.Strong understanding of regulatory and phase-appropriate QC expectations for clinical development.Demonstrated experience managing testing activities at external testing laboratories.Excellent scientific judgement, communication, cross-functional collaboration, and influencing skills.Demonstrated ability to organize, plan, and execute multiple tasks with flexibility for changing priorities and plans.Must think critically and creatively and be able to work independently to determine appropriate strategy and resources for resolution of problemsKnowledge of medical devices and combination products is a plus.Gilead Core ValuesIntegrity (Doing What’s Right)Inclusion (Encouraging Diversity)Teamwork (Working Together)Excellence (Being Your Best)Accountability (Taking Personal Responsibility)The salary range for this position is: $169,320.00 - $219,120.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.For additional benefits information, visit: * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.For jobs in the United States:Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.