Sr Director, R&D Quality

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.

R&D Quality is seeking a Senior Director, Quality Operations Excellence Lead to join our R&D Program Quality Team. In this role you will lead and set a strategy for ensuring the execution of Quality Oversight activities for all products in development ough the establishment of standards and promoting best practices, you will drive optimized performance for key focus areas critical to the success of R&D Quality.

Acting as trusted business partners you and your team will work closely with R&D Program Therapeutic Area Leads to oversee the consistent performance and outputs of key activities such as study oversight plans, critical quality event management, serious breach assessments, study/program/therapeutic area analytics and Quality Briefs. Reporting to the Executive Director, R&D Program Quality, you will also be a key member of the R&D Quality and Medical Governance Extended Leadership Team advancing a culture of Quality across Gilead.

We seek an individual with strong leadership skills, expert drug development and GCP knowledge, and advanced understanding of the application of Quality Risk Management principles.

You will be a part of a dynamic global Quality leadership team that strives to be a trusted business partner and promotes a culture of Quality in all we do.

• Design and implement an integrated Quality Operations Strategy for the Gilead R&D portfolio.
• Establish standards, tools & performance indicators for key activities including quarterly metrics & risk reporting for Program/Study Quality Briefs, Due Diligence, Quality Oversight Plans, critical quality event management, serious breach assessment and reporting.
• Lead the analysis and interpretation of key quality data in Program/Study Quality Briefs for the presentation and reporting to functional and executive leadership.
• Lead and oversee lessons learned activities driving continuous improvement.
• Optimize R&D Program Quality performance by implementing a flexible centralized resourcing model for high-demand activities.
• Oversee and lead critical quality event investigations and serious breach assessments.
• Act as point of contact (PoC) for due diligence activities ensuring collaboration with Regulatory and Safety leads.
• Collaborate with Oncology, Virology and Inflammation Program Leads in assessing cross therapeutic area risks.
• Act as PoC for Program Quality for key initiatives within Global R&D Quality and RSQ.
• Providing guidance and training for core quality management capabilities such as risk management, quality event management and issue escalation, and deviation and CAPA management.
• Establish strong partnership with key business stakeholders, including Clinical Development, Clinical Operations, Regulatory, Safety, and Clinical Data Sciences.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Serve as an expert and provide guidance on and interpretation of…