Senior Scientist, Quality Control
About The Position
Gilead is hiring a Senior Scientist, Quality Control to provide QC leadership and analytical subject matter expertise for assigned products throughout their commercial lifecycle. The role provides end-to-end QC oversight across manufacturing, testing, analytical methods, stability, regulatory submissions, and commercial activities, while coordinating QC deliverables and managing risks with cross-functional partners. The position oversees contract testing laboratories and supports investigations, deviations, change controls, and resolution of testing-related issues. It leads analytical method lifecycle management, including implementation, transfer, validation or verification, changes, performance monitoring, and ongoing suitability for commercial testing. The role also contributes QC input to regulatory submissions and post-approval changes, coordinates reviews of specifications and testing requirements, and assesses QC impacts of product changes. The Senior Scientist serves as a QC subject matter expert and technical escalation point, communicates QC risks and priorities, and authors, reviews, and maintains GMP documentation. Gilead also describes leadership accountabilities that include creating inclusion, developing talent, 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.
- Commercial Quality Control experience and knowledge of industry best practices and trends for reference standards, stability, and/or raw materials.
- Deep knowledge and experience in biologics quality control, with awareness of shifting industry trends.
- 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 innovative solutions to complex problems requiring ingenuity and creativity.
- 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, work independently, and determine appropriate resources to resolve problems.
- 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 QC 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 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 the 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 cross-functionally 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, develop talent, and empower teams in accordance with the stated leader accountabilities.
Benefits
- Discretionary annual bonus eligibility.
- Discretionary stock-based long-term incentives; eligibility may vary by role.
- Paid time off.
- Company-sponsored medical insurance.
- Company-sponsored dental insurance.
- Company-sponsored vision insurance.
- Company-sponsored life insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
