Senior Director - Business Operational Excellence (BOE)

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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
 

Regulatory Affairs Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work!  Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value.  In doing this we unleash and enable our people to be purposeful and impactful!
 

The Business Operational Excellence function works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process development and excellence, controlled documentation development and management and effective learning programs. In addition, leadership of the Incubation Hub will include oversight of all RSQ initiatives involving GRA.  The Business Operational Excellence Functional Head will play a leadership role in developing and implementing Global Regulatory Affairs infrastructure, compliance, process, and capability development.  The wider Business Operational Excellence team, incorporating Business Process Management and Excellence, the Quality and Compliance Centralized Process Team (CPT) and dedicated staff responsible for Regulatory Learning & Development, will partner closely across Regulatory Affairs and the wider Gilead organization to provide services including, but not limited to GRA business process support, audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications and regions.  The team will also identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities (example: Manage Initiatives Portfolio, Manage Capability and Process Frameworks) across the global organization (US, EU, Japan, China, Australia, Canada, Intercontinental and Global Patient Solutions).

EXAMPLE RESPONSIBILITIES:

• Leads the Regulatory Business Process Management and Excellence Team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated staff, with responsibilities for identification, development, refinement and continuous improvement of processes, standards, practices, efficiencies and capabilities within the Regulatory Affairs Department and wider company.

• Leads the incubation period for new process and departmental initiatives and appropriate RA capabilities (example:  Manage Initiative Portfolio, Manage Capability and Process Frameworks).

• Hires, develops, and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development, and career interests.

• Makes significant contributions to our abilities to hire, develop and