QA Specialist III

Gilead Sciences•La Verne, CA

About The Position

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.

Requirements

6+ years of relevant experience in a GMP environment related field and a BS or BA.
4+ years of relevant experience and an MS.
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.

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.