Director, Risk Based Quality 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 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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

RESPONSIBILITIES:

• Serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.
• Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees.
• Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements.
• Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM.

Study Risk Assessment and Mitigations

• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.
• Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management. 
• Contribute to the development of new central monitoring tools to address risks and support study oversight, Contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, performance indicators, and develop the study’s Central Monitoring plan.
• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.
• Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.
• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.

Operational Excellence

• Lead the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.
• Manage RACT libraries, driving consistency across programs and therapeutic areas.
• Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation. 
• Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.
• Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.
• Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.
• Represent Gilead in industry-wide collaborations, contributing thought leadership and sharing best practices.
• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

Team Leadership

• May manage a team of direct and indirect reports, supporting the recruitment, development, and retention of diverse top talent.
• Provide coaching and mentorship to direct reports, aligning performance feedback with individual development goals and career aspirations.
• Establish goals and expectations for direct reports, regularly reviewing performance and ensuring team deliverables adhere to internal processes and regulatory requirements.
• Overse