Associate Director, R&D Corrective Actions & Preventive Actions (CAPA) Operations Management

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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
 

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth, and retention of talent, and empower teams to align and achieve goals. 

JOB DESCRIPTION 

 The Associate Director of R&D CAPA (Corrective and Preventive Actions) Operations Management is responsible for overseeing the R&D CAPA program and associated processes, ensuring its effectiveness and continuous improvement. This role involves managing CAPA administration, CAPA training, setting record standards, and maintaining high-quality standard for records and data. The successful candidate will collaborate with various business areas, lead strategic process improvement projects, support quality forums, and establish CAPA operational measures to ensure the organization’s compliance and quality objectives are met.  

This role reports into the R&D Quality Issue Management function, which is responsible for driving the integration and peak performance of R&D’s Quality Management System elements of Deviation, CAPA, and Escalation across Clinical Development and Post-Marketing.  

PRIMARY RESPONSIBILITIES 

CAPA Program Management: 

• Lead the R&D CAPA program, ensuring adherence to regulations and industry best practices. 

• Develop and maintain CAPA procedures, policies, and documentation specific to R&D activities. 

• Establish a continuous improvement program for CAPA operations, driven through performance measures and lesson’s learned opportunities. 

• Implement, monitor and report CAP