Assoc Director, Quality Assurance

Gilead Sciences • Foster City, CA

17h • $182,070 - $235,620

About The Position

Gilead is hiring an Associate Director of Quality Assurance to provide quality oversight of GMP manufacturing and QC operations throughout the product lifecycle, from master cell bank through drug product. The role oversees external QC laboratories and ensures that analytical method qualification, verification, and validation comply with cGMP, ICH, and internal standards. It reviews investigations and quality records, applies risk management principles, and partners with cross-functional teams to address quality risks affecting product quality, patient safety, and supply continuity.

The position supports manufacturing, QC, material receipt and shipping, and the startup of digital manufacturing and data solutions. It reviews and approves manufacturing and testing records, deviations, investigations, change controls, CAPA, and GMP documentation. The role also participates in audits and inspections, monitors regulatory requirements, drives quality-process improvements, and provides leadership, development, and mentoring to Quality personnel. On-call Quality Assurance support may be required.

The position calls for in-depth GMP and/or GLP, QA, computer systems validation, and ICH knowledge; familiarity with quality improvement methods and risk-management tools; and extensive hands-on experience supporting biologics, GMP manufacturing, and QC operations. Previous Quality people-management experience is required. The stated salary range is $182,070 to $235,620, and the role may also be eligible for a discretionary annual bonus, stock-based long-term incentives, paid time off, and benefits.

Requirements

• 10 or more years of relevant experience in a GMP-related environment and a bachelor's degree in science or a related field; or 8 or more years of relevant experience and a master's degree; or 5 or more years of relevant experience and a PharmD or PhD.
• Extensive hands-on experience supporting biologics, GMP manufacturing, and QC operations.
• Proven experience leading investigations, CAPA, and change management in a GMP operational environment.
• Strong understanding and experience of materials management, manufacturing, analytical methods, and testing systems within a GMP environment.
• Previous experience in people management within Quality.
• Strong cross-functional collaboration and communication skills.
• In-depth knowledge of GMP and/or GLP, QA principles and practices, computer systems validation, and ICH guidelines.
• Excellent verbal, written, and interpersonal communication skills.
• Knowledge of Six Sigma, DMAIC methodology, performance measures, and quality improvement statistics.
• Working knowledge of risk-management tools such as HACCP and/or FMEA.

Nice To Haves

• Experience supporting Health Canada, FDA, or other regulatory inspections.
• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager) or another industry-recognized professional organization.

Responsibilities

• Provide Quality Assurance oversight of GMP manufacturing and QC testing operations throughout the product lifecycle, from master cell bank to drug product.
• Provide strategy and oversight for external QC laboratories and review and approve method qualification, verification, and validation protocols, reports, and methods.
• Review and approve contract-partner laboratory investigations, including OOS, OOT, and deviations; ensure root cause analysis, CAPA, and aligned product-quality and disposition decisions.
• Apply Quality Risk Management principles and partner with Manufacturing and QC to identify, assess, document, and mitigate quality risks.
• Resolve quality issues arising during manufacturing, laboratory activities, and material receipt and shipping in partnership with Manufacturing and QC.
• Oversee implementation and manufacturing workflow development for digital manufacturing and data solutions with manufacturing, automation, engineering, and information technology teams.
• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely disposition.
• Evaluate operational and quality risks related to new product introduction.
• Participate in internal GMP audits and routine walk-throughs of Manufacturing, QC, and Warehouse areas.
• Serve as a key Quality contact during regulatory inspections and internal audits, including preparation and response to findings.
• Monitor regulatory requirements and proactively assess potential 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.
• Lead, develop, and mentor 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 tasks and ensure product quality.
• Maintain working knowledge of Health Canada, FDA, and global GMP expectations.
• Support People Leader accountabilities by fostering inclusion, developing talent, and empowering teams.

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.
• Benefits are subject to the terms and conditions of applicable plans.

What This Job Offers

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