Director, Intelligence Compliance & Quality Integration Management

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 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 fulfill their aspirations. Join Gilead and help create possible, together.

Job Description

POSITION OVERVIEW:

This role focuses on the health and evolution of the Gilead R&D Quality Management System (QMS). Key responsibilities include driving intelligence change management activities, such as implementing new legislation to ensure proactive compliance, and serving as R&D Quality integration lead to facilitate effective integration with Gilead’s R&D QMS, supporting collaborations. The role involves building and improving core capabilities related to Gilead’s QMS across GLP, GCP, GVP requirements, and core elements like audits, inspections, vendor quality, reporting, analytics, documentation, and training. The position requires interfacing with various teams including Clinical Development, Legal, IT, and Manufacturing.

EXAMPLE RESPONSIBILITIES:

• Support development and execution of a GxP compliance intelligence change management program.
• Mine, analyze, evaluate, and escalate risks associated with emerging intelligence.
• Lead impact assessments and implementation planning for regulatory changes.
• Evaluate SOPs and procedures to ensure compliance and relevance.
• Contribute to external engagement programs and knowledge management.
• Lead continuous improvement activities on inspection management processes.
• Support inspection readiness and conduct activities.

QMS and Quality Integration Responsibilities:

• Create and maintain a central repository for R&D integration documentation.
• Develop procedures and tools to support R&D Quality’s integration activities.
• Advise on quality considerations for integrations and coordinate risk assessments.
• Develop templates and monitor compliance of integration activities.
• Maintain records and update the QMS Manual as needed.

REQUIREMENTS:

We seek candidates with a background in life sciences and significant experience in biopharma quality or compliance roles, including advising on regulations, risk management, and continuous improvement. Strong communication, leadership, and project management skills are essential. Knowledge of GxP standards, drug development, and industry regulations is required. Willingness to travel may be necessary.

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