Senior Specialist, Quality Assurance

Gilead Sciences • Foster City, CA

1d • $136,340 - $176,440 • Onsite

About The Position

The Senior Specialist, Quality Assurance is an individual-contributor, site-based role supporting Gilead’s Foster City Manufacturing New Chess Facility (NCF). The role supports facility startup, operational readiness, and ongoing manufacturing and analytical operations, aligning quality activities with manufacturing, digital, quality control, and compliance priorities.

The position provides quality oversight of GMP operations, including review and approval of contract-partner laboratory investigations and GMP documentation; oversight of risk assessments; review of manufacturing, environmental-monitoring, and quality-control data; and maintenance of processes that support product quality and compliance with GMP and GLP requirements. The role also supports audits, inspections, investigations, CAPAs, new-product startups, continuous improvement, and cross-functional operational projects. It provides on-call QA support to Manufacturing and QC as required and may provide leadership, development, and mentoring for Quality personnel.

The role requires at least 6 years of relevant GMP-environment experience with a BS or BA, or at least 4 years with an MS. Hands-on experience supporting biologics, GMP manufacturing, and QC operations is required. The salary range is $136,340–$176,440. The position may also be eligible for a discretionary annual bonus and stock-based long-term incentives, paid time off, and company-sponsored medical, dental, vision, and life insurance.

Requirements

• At least 6 years of relevant experience in a GMP-related field and a BS or BA, or at least 4 years of relevant experience and an MS.
• Hands-on experience supporting biologics, GMP manufacturing, and QC operations.
• Strong understanding and experience of materials management, manufacturing, and analytical methods and testing systems in a GMP environment.
• Strong cross-functional collaboration and communication skills.
• Proficiency in GMPs and/or GLPs and application of QA principles, concepts, industry practices, and standards.
• Ability to manage multiple projects and priorities effectively.
• Analytical and conceptual skills.
• Understanding of international quality-systems regulations and ability to adopt best-in-class systems and processes.
• Excellent verbal communication, technical writing, and interpersonal skills.
• Working knowledge and good proficiency in Microsoft Office applications.

Nice To Haves

• Knowledge of Six Sigma, DMAIC methodology, performance measures, and quality-improvement statistical methods.
• Working knowledge of risk-management tools such as HACCP and/or FMEA.

Responsibilities

• Review and approve contract-partner laboratory investigations, including OOS, OOT, and deviation investigations, ensuring robust root-cause analysis, CAPAs, and decisions that protect product quality and disposition.
• Apply Quality Risk Management principles and oversee risk assessments in collaboration with Manufacturing and QC operations.
• Participate in creating or revising controlled documents such as SOPs, specifications, and methods.
• Maintain programs and processes that support high-quality products and compliance with current GMPs and GLPs.
• Review manufacturing, environmental-monitoring, and quality-control data for in-process and finished products.
• Work with operating entities to ensure inspections, statistical process-control analyses, and audits are conducted on an ongoing basis.
• Participate in developing quality-product training programs, as needed.
• Conduct or coordinate investigations and recommend corrective and preventive actions related to manufactured products.
• Work with Research and Development during new-product startups and establish checkpoints for new products and processes.
• Assist with or lead compliance audits and interface with regulatory agencies, as required.
• Participate in internal GMP audits and routine walkthroughs of Manufacturing, QC, and Warehouse areas.
• Support regulatory inspections and internal audits; monitor regulatory requirements and proactively assess operational compliance risks.
• Approve GMP documentation, including risk assessments, procedures, master batch records, specifications, and analytical methods.
• Drive continuous improvement of quality processes supporting GMP operations.
• Provide leadership, development, and mentoring for Quality personnel supporting GMP operations.
• Partner with Manufacturing, QC, Process Development, Engineering, Supply Chain, and Quality management on corporate and site initiatives.
• Lead or support quality-related operational projects and improvement initiatives.
• Provide on-call Quality Assurance support to Manufacturing and QC operations, as required.
• Use risk-based decision-making to prioritize work and ensure product quality.
• Maintain working knowledge of Health Canada, FDA, and global GMP expectations.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior