QA Specialist III

Regulatory Jobs; La Verne (CA); On-site; USD 107,000 - 139,000; Full time

Job summary

Gilead Sciences is seeking a Quality SME for SAP QM with a strong GMP background to translate business needs into system requirements and drive process improvements. The role collaborates with Quality, Manufacturing, Supply Chain and IT to support global deployments, testing, and documentation.

The ideal candidate has 6+ years in GMP, or 4+ years with an MS, plus experience with MES/LIMS and document management systems. On-site in California, with eligibility for potential bonus and benefits.

Qualifications

• 6+ years of relevant GMP experience and a BS or BA in computer science.
• 4+ years of relevant experience with an MS in computer science.
• Prior pharma or biopharmaceutical industry experience preferred.
• Strong GMP and Quality Systems knowledge.

Responsibilities

• Serve as a Quality SME for SAP QM and Digital Quality solutions translating GMP business needs into system requirements and process improvements.
• Support SAP QM incident management, sustainment, and solution releases
• Drive standardization and optimization of quality processes (e.g., material status, usage decision, jurisdictional control)
• Partner cross‑functionally with Quality, Manufacturing, Supply Chain, and IT
• Support global deployments through testing, change management, documentation, and training
• Contribute to continuous improvement and KPI‑based performance monitoring
• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.
• Participates in developing Standard Operating Procedures to ensure quality objectives are met.
• May facilitate external audits/inspection processes as SAP SME, supporting implementation of corrective actions as needed.
• May assist with compliance audits as required.

Skills

Quality SME for SAP QM

GMP environment experience

Incident management

Cross-functional collaboration

Education

BS in Computer Science

MS in Computer Science

Tools

SAP QM

MES

LIMS

Document management systems

Job description

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

A computer science background is required, along with hands-on experience in backend development and coding practices.

Roles/Responsibilities:

• Serve as a Quality SME for SAP QM and Digital Quality solutions translating GMP business needs into system requirements and process improvements

• Support SAP QM incident management, sustainment, and solution releases

• Drive standardization and optimization of quality processes (e.g., material status, usage decision, jurisdictional control)

• Partner cross‑functionally with Quality, Manufacturing, Supply Chain, and IT

• Support global deployments through testing, change management, documentation, and training

• Contribute to continuous improvement and KPI‑based performance monitoring

• Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

• Participates in developing Standard Operating Procedures to ensure quality objectives are met.

• May facilitate external audits/inspection processes as SAP SME, supporting implementation of corrective actions as needed.

• May assist with compliance audits as required.

Basic Qualifications:

• 6+ years of relevant experience in a GMP environment related field and a BS or BA. (computer science)

OR

• 4+ years of relevant experience and an MS.

Preferred Qualifications:

• Prior experience in pharmaceutical or biopharmaceutical industry.

• Strong GMP and Quality Systems knowledge

• Familiarity with MES, LIMS (or GLIMS), and document management systems

• Demonstrates strong verbal, technical writing and interpersonal skills.

• Demonstrates proficiency in Microsoft Office applications.

• SAP system development, coding and/or validation.

• A computer science background is required, along with hands-on experience in backend development and coding practices.

The salary range for this position is: $107,185.00 - $138,710.00. 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 [e-mail] for assistance.

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

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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: