Assoc Director, Quality Assurance

Gilead Sciences • Foster City, CA

1d • $182,070 - $235,620

About The Position

Gilead is hiring an Associate Director, Quality Assurance to provide quality oversight and leadership for GMP manufacturing and QC operations throughout the product lifecycle, from master cell bank through drug product. The role oversees external QC laboratories and method lifecycle activities, reviews laboratory investigations, applies quality risk management, and partners with operational and cross-functional teams to resolve quality issues and protect product quality, patient safety, and supply continuity. It also supports digital manufacturing and data solution implementation and evaluates risks associated with new product introductions.

The position supports GMP compliance through audits, walk-throughs, regulatory inspections, and monitoring of regulatory requirements. It approves GMP records and documentation, drives continuous improvement of quality processes, and leads or supports operational initiatives. The role provides leadership, development, and mentoring for Quality personnel and on-call QA support to Manufacturing and QC as required. A strong working knowledge of Health Canada, FDA, and global GMP expectations is required.

Requirements

• 10 or more years of relevant experience in a GMP-related field 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 of materials management, manufacturing, analytical methods, and testing systems in a GMP environment.
• Previous experience in Quality people management.
• Strong cross-functional collaboration and communication skills.
• In-depth knowledge of GMPs and/or GLPs, QA principles, industry practices, and standards.
• Understanding of 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.
• ASQ certification, such as Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager, or certification from 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.
• Develop quality strategy and oversee external QC laboratories and method qualification, verification, and validation, including review and approval of protocols, reports, and methods.
• Review and approve contract-partner laboratory investigations, including OOS, OOT, and deviation investigations, and ensure robust root cause analysis and CAPA.
• Apply Quality Risk Management principles and collaborate with Manufacturing and QC to assess and mitigate quality risks.
• Ensure quality risk decisions are justified, documented, and aligned with internal procedures and regulatory expectations.
• Partner with Manufacturing and QC to resolve issues involving manufacturing, laboratory activities, and material receipt and shipping.
• Oversee implementation and workflow development for digital manufacturing and data solutions in collaboration with manufacturing, automation, engineering, and IT teams.
• Review and approve manufacturing and test records, deviations, investigations, change controls, and CAPA to support product quality and 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 responses 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.
• 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 QA 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.
• Create an inclusive team environment, develop talent through coaching and feedback, and empower teams by aligning goals and removing barriers.

Benefits

• May be eligible for a discretionary annual bonus.
• May be eligible for discretionary stock-based long-term incentives, depending on 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