Senior Scientist, Quality Control

Gilead Sciences • Foster City, CA

2d

About The Position

The Senior Scientist, Quality Control at Gilead serves as the primary QC representative for assigned products, providing leadership and analytical subject matter expertise across product teams and cross-functional forums. The role provides end-to-end QC oversight across manufacturing, testing, analytical methods, stability, regulatory submissions, and commercial lifecycle activities. It also oversees contract testing laboratories and supports resolution of testing-related issues, investigations, deviations, and changes.

The position leads analytical method and QC testing strategy lifecycle management, contributes QC expertise to regulatory submissions and post-approval changes, and coordinates review and approval of commercial specifications. The role partners with Quality, Manufacturing, Regulatory, Supply Chain, and technical functions to manage QC deliverables, risks, and product changes. It serves as a technical escalation point and authors, reviews, and maintains GMP documentation. The position also carries people-leader accountabilities focused on inclusion, talent development, and empowering teams.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, or a related field and 8 or more years of relevant experience; or a master's degree in one of these fields and 6 or more years of relevant experience; or a Ph.D. in one of these fields and 2 or more years of relevant experience.
• Deep knowledge and experience in biologics quality control.
• Experience with Commercial Quality Control and knowledge of industry best practices and trends for reference standards, stability, and/or raw materials.
• In-depth understanding and application of GMP principles, concepts, practices, and standards in the United States and internationally.
• Ability to develop and improve complex concepts, techniques, standards, and new applications based on quality principles and theories.
• Ability to develop solutions to complex problems requiring ingenuity, creativity, and innovation.
• Ability to exercise judgment and independently determine and take appropriate action where precedent may not exist.
• Proven ability to work with senior management to develop and ensure implementation of company-wide long-term solutions.
• Demonstrated ability to develop a vision for Quality Control functions and shape the function's capabilities to fulfill that vision.
• Demonstrated ability to influence processes and outcomes across functions.
• Ability to think critically and creatively and work independently to determine appropriate resources for problem resolution.
• Strong organizational and planning skills.
• Excellent verbal and written communication skills and collaborative interpersonal skills.

Responsibilities

• Serve as the primary QC representative for assigned products, providing QC leadership and analytical subject matter expertise across product and analytical sub-teams, PDM teams, PQTs, and other cross-functional forums.
• Provide end-to-end QC oversight for assigned products, coordinating activities and deliverables across manufacturing, testing, analytical methods, stability, regulatory submissions, and commercial lifecycle activities.
• Lead oversight of contract testing laboratory activities, including testing execution, GMP sample shipment coordination, laboratory investigations and deviations, change controls, and resolution of testing-related issues.
• Provide analytical and QC input to manufacturing investigations and deviations, partnering with Manufacturing, Quality, technical functions, and testing laboratories to assess product and method impact and support appropriate resolution.
• Lead lifecycle management of analytical methods and associated QC testing strategies, including method implementation, transfer, validation or verification, changes, performance monitoring, and continued suitability for commercial testing.
• Provide QC input and review for regulatory submissions and post-approval changes, including BLA/NDA content, responses to regulatory questions, and assessment of QC impacts associated with filing commitments.
• Coordinate review and approval of commercial specifications and associated testing requirements, ensuring alignment with regulatory filings, analytical capabilities, product knowledge, and applicable quality requirements.
• Provide QC oversight and coordination for product changes, assessing impacts to analytical methods, specifications, testing laboratories, sample management, stability, and other QC deliverables and ensuring appropriate implementation.
• Partner with Quality Control, Quality Assurance, Manufacturing, Regulatory, Supply Chain, and other technical functions to identify, communicate, and manage QC deliverables, risks, dependencies, and issues throughout the product lifecycle.
• Serve as a QC subject matter expert and technical escalation point, providing recommendations, driving resolution of analytical and testing issues, and communicating QC risks, decisions, and priorities to cross-functional stakeholders.
• Author, review, and maintain GMP documentation, including protocols, reports, SOPs, deviations, change controls, CAPAs, and study closeout documentation.
• Create inclusion by modeling inclusive leadership and embedding the value of diversity in team management.
• Develop talent by coaching employees on current performance and future potential and ensuring they receive feedback and development insight.
• Empower teams by aligning goals with organizational objectives, holding teams accountable, removing barriers, and connecting them to the broader organization.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives, with eligibility varying by role.
• 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