QA Specialist III

仕事内容

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

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.

Key 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.

Basic Qualifications:

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

• Masters' degree and 3+ years of relevant experience

​

Preferred Qualifications:

• 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.

People Leader Accountabilities:

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is: $117,895.00 - $152,570.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

For jobs in the United States:

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.