QA Specialist III

Gilead Sciences • Foster City, CA

5d

About The Position

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. This QA Specialist III serves as a systems and analytics-focused quality subject matter expert responsible for the governance, optimization, and effective use of GMP quality and enterprise systems to support the External Quality organization. The position applies advanced analytics and system-derived insights to monitor process performance, identify trends and emerging risks, and support continuous process verification and ongoing quality improvement. This includes leveraging statistical methods, performance metrics, and dashboards to translate complex system data into actionable quality intelligence. The QA Specialist III leads organizationally specific system-related operational change management efforts within those respective platforms, assessing data, process, and compliance impacts of changes to quality systems and workflows. The role also provides expert, data-driven support for health authority interactions, audits, and inspections related to electronic systems, data integrity, and the effective use of quality data.

Requirements

• Bachelor's degree and 5+ years of relevant experience; OR Masters' degree and 3+ years of relevant experience

Nice To Haves

• Demonstrates advanced analytical thinking with the ability to interpret complex datasets, identify trends, and translate data into actionable insight
• Demonstrates strong technical writing, data storytelling, and visualization skills to clearly communicate complex quality and system-related information emonstrates advanced proficiency in analytics-enabled tools with the ability to automate or streamline quality reporting where appropriate
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards into day-to-day operations to adopt best in class systems & processes
• Demonstrates ability to effectively manage multiple projects/priorities and collaborate with key stakeholders for responsibilities
• Demonstrates excellent verbal communication and interpersonal skills, especially with the ability to ‘simplify the complex’ when describing scope of work
• Demonstrates the ability to learn quickly in a fast-paced, highly regulated environment.
• Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods are beneficial.
• Working knowledge of Risk Management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
• Working knowledge and experience in interacting with regulatory authorities and other governing bodies / agencies is beneficial.
• Experience and working knowledge with Artificial Intelligence, Agentic Frameworks, and Large Language Models is beneficial.

Responsibilities

• Serves as a systems and analytics-focused quality subject matter expert supporting the External Quality organization through governance, optimization, and effective use of quality data and enterprise systems.
• Develops, maintains, and interprets External Quality metrics, dashboards, and performance reports that translate complex system data into actionable quality intelligence for cross-functional stakeholders to support compliant operations and timely decision making.
• Applies advanced analytics and system-derived insights to monitor process and external quality performance, identify trends and emerging risks, and support ongoing quality improvement activities.
• Serves as an SME and influencer with Data Analytics, Quality Center of Excellence, IT, and Digital Quality organizations on cross-functional and cross-departmental digital transformation initiatives supporting the greater PDM Quality organization
• Supports and/or leads manual process automation initiatives within the External Quality organization to improve ways of working
• Evaluates and implements system and process improvements using statistical methods, performance measures, and risk-based approaches to enhance efficiency, compliance, and data usability.
• Provides expert, data-driven support for health authority interactions, audits, and inspections related to electronic systems, data integrity, analytics outputs, and the effective use of quality data.
• Authors and/or reviews system-related controlled documentation (e.g., SOPs, system procedures, data governance standards, work instructions) to ensure clarity, usability, and regulatory alignment in support of processes
• Contributes to training, knowledge sharing, and continuous improvement initiatives by advancing system expertise, analytics capability, and data-driven quality practices.

Benefits

• This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
• Benefits include company-sponsored medical, dental, vision, and life insurance plans.
• For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing

What This Job Offers

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