Quality Engineer III

Gilead Sciences • Oceanside, CA

1d • Onsite

About The Position

The Quality Engineer III serves as a subject matter expert in Computer System Validation (CSV), and Commissioning, Qualification, and Validation (CQV), Data Integrity, and Quality Risk Management. This role provides independent Quality review and oversight of qualification, validation, and compliance activities to ensure systems, facilities, equipment, and processes meet applicable regulatory and company requirements. The position partners with cross-functional teams to evaluate quality impacts, manage compliance risks, support inspection readiness, and drive continuous improvement. Applying sound technical judgment and risk-based quality principles, the Quality Engineer III helps strengthen the Quality Management System (QMS) and supports consistent, compliant, and reliable operations. The role also supports QMS activities, including change controls, risk assessments, investigations, internal and regulatory audits, and compliance assessments to maintain regulatory compliance and inspection readiness.

Requirements

• Bachelor's degree in Engineering, Life Sciences, Computer Science, Quality, or a related technical discipline with 5+ years of experience in Quality, Validation, Compliance, Manufacturing, or a regulated pharmaceutical/biotechnology environment; OR Master's degree in a related field with 3+ years of relevant experience.
• Experience supporting Computer System Validation (CSV), Commissioning, Qualification and Validation (CQV), Quality Systems, or Data Integrity programs in a regulated environment.
• Working knowledge of GxP, FDA, EU GMP, 21 CFR Part 11, Annex 11, and Data Integrity principles.
• Experience with quality processes including change controls, deviations, CAPAs, investigations, risk assessments, and audit support is a plus.
• Ability to review and interpret technical documentation, validation deliverables, and quality records for compliance with regulatory and company requirements.
• Strong verbal and written communication skills with the ability to effectively collaborate across Quality, Manufacturing, Engineering, Validation, and Information Technology functions.

Nice To Haves

• Experience in the biopharmaceutical, biotechnology, cell therapy, gene therapy, or pharmaceutical manufacturing industry.
• Experience supporting regulatory inspections, internal audits, and compliance initiatives.
• Familiarity with validation lifecycle activities for computerized systems, manufacturing equipment, and laboratory systems.
• Knowledge of quality risk management methodologies.
• Ability to develop and evolve complex quality concepts, standards, and methodologies based on sound quality engineering principles.
• Experience with electronic quality management systems (eQMS) and document management systems.

Responsibilities

• Provide quality oversight for Computer System Validation (CSV), Commissioning, Qualification, and Validation (CQV) activities.
• Maintain site Data Integrity and Quality Risk Management programs to ensure compliance with regulatory and company requirements.
• Review and approve validation, qualification, and risk assessment documentation, including protocols, reports, and technical assessments.
• Perform quality impact assessments and technical evaluations for change controls, deviations, investigations, and CAPAs.
• Partner with cross-functional teams to ensure systems, equipment, and processes are qualified and maintained in compliance with applicable regulations and internal procedures.
• Support internal audits, regulatory inspections, and compliance readiness activities.
• Analyze quality data and metrics to identify trends, support decision making, and drive continuous improvement initiatives.
• Lead or support risk assessments related to systems, facilities, materials, and manufacturing processes.
• Conduct gap assessments and compliance reviews to identify and remediate regulatory or procedural risks.
• Provide technical guidance and support for validation, data integrity, and quality compliance activities across the site.
• Review technical, validation, and quality records to ensure accuracy, completeness, and regulatory compliance.
• Participate in projects and initiatives that strengthen quality systems, compliance programs, and operational excellence.
• Additional duties as assigned.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

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