Director, R&D Quality, Inspection 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.

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, supporting the drive to a continuous improvement company culture. You will lead development and maintenance of a comprehensive and connected framework for continually improving inspection management, supporting R&D personnel with the readiness, preparation, conduct and follow-up for GCP, GLP/GCLP and GPV inspections by regulatory health authorities.

You will typically represent Gilead in regulatory inspections as a lead representative and point-of-contact for regulatory agencies. You will collaborate cross-functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with Gilead's Quality Management System (QMS) and related policies and procedures.

You will play a role in development and maintenance of an intelligence change management system and framework. You will typically play a key role in developing the short- and long-range R&D inspections management strategy, infrastructure and resource plans. You may also support senior colleagues in R&D Quality Inspection Management. You may have one or more direct reports. You will also play a leadership role in special projects that advance the capabilities and/or resources of the overall R&D Quality Inspection Management group and/or the wider R&D Quality organization.

As a Director, R&D Quality, Inspection Management, at Gilead you will ...

• Lead efforts to increase the commitment to quality in individuals and a culture of quality within the organization.
• Area of responsibility may be limited to Clinical Compliance, Laboratory Compliance, or Electronic Systems Compliance.
• Work is performed under consultative direction towards corporate and department goals and objectives. Ensures that tools are appropriate and fit for purpose.
• Supervise the coordination of the work of others.
• Ensures annual audit plans are developed and audit activities are completed according to plan across sites and monitors resources and budget for audits.
• Identifies new contract auditors, oversees the establishment of agreements and ensures all commitments are met by contract auditors.
• Responsible for the oversight of SOPs evaluation and implementation.
• Keeps a watch toward changes in industry/regulatory environment that would necessitate future changes and proactively initiates discussions so the company is prepared to respond to such changes.
• Contributes to or leads…