Associate Director, R&D Quality Business Partner

For Current Gilead Employees and Contractors:

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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
 

You will act as the R&D Quality Business Partner to assigned groups, such as Gilead R&D functions or vendors supporting Gilead R&D. You will provide strategic, expert advice and consultation on R&D quality, risk and continuous improvement with impact across cross-functional Good Practices. You will educate assigned groups on Gilead quality policy and procedural standards, GxP regulations and other requirements. You will provide expert advice specifically on GCLP risk minimization and mitigation. You will help business and vendor partners understand potential impacts of risk and alternatives to best address risk. You will also provide leadership support in escalating quality risks or issues. You will participate in and/or lead Quality forums, cross-functional teams and/or projects. You will act as the central point of contact for QMS-related communications to assigned groups; consolidating and channeling just-in-time information and resources to assist assigned groups. You will collaborate with other R&D Quality groups to ensure just-in-time support and resources to assigned groups, including - data, reporting, training, audit, inspection, risk assessment and deviation/ CAPA management support. You may represent Gilead in regulatory inspections. Where applicable, you will play a lead role in R&D vendor qualification, on-boarding, relationship management and governance.  You may provide GCLP/GLP support for company integrations, as applicable. 

EXAMPLE RESPONSIBILITIES:  

• Serves as the Quality Business Partner lead for assigned Gilead R&D functions, programs and/or vendors. Handles multiple projects simultaneously and ensures overall and timely completion of tasks. 

• Works closely with business and/or vendor teams to provide expert quality information, manage identified issues, and support continuous improvement. 

• Acts as Subject Matter Expert performing global risk assessment for all activities performed by assigned functions, vendors or relevant to assigned R&D programs.  

• Collaborates with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance on all internal quality audits, regulatory agency inspections, risk assessment, deviations and CAPA activities.  

• Assists in readiness preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings. 

• Supports deviation identification, reporting, and CAPA development.  

• Lead company integration related activities for GCLP/GLP and related vendors 

• Leads intra/inter-departmenta