Executive Director, R&D Quality Audit

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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
 

Position Overview

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams, and external partners as we strive to cure unmet medical needs?

R&D Quality is seeking an Executive Director, Head of Audit to join our Leadership Team that oversees GCP, GLP/GCLP and GVP activities at Gilead. In this role you will be responsible for providing global strategic direction and leadership for the R&D Quality audit program to assure compliance with regulatory requirements across Research & Development (R&D) as well as supporting the continuous improvements of the R&D Quality Systems. You will have accountability for these programs, assuring independent oversight, effectiveness in delivery on objectives and a strong quality voice.

Advanced leadership skills and a partnership mindset, anchored by expert knowledge of the regulations governing preclinical research, drug development and post marketing activities (i.e., GCP, GLP/GCLP, and GVP), as well as a keen understanding of process controls will enable success in this role.

Key Responsibilities

Audit Program Leadership

• Leads and ensures the establishment of the annual R&D audit strategy using a risk-based approach, taking into account regulatory requirements, industry trends and portfolio requirements.

• Ensures the execution of the strategic audit plan, leveraging internal and external resources.

• Assures operational excellence of the audit program, including the timeliness and quality   of audit reports, adherence to budget and communication of key findings.

• Partners closely with risk and analytics group to design and deliver audit metrics to identify trends utilizing analytics and industry intelligence.

• Provides organization with recommendations for risk mitigation and continuous improvement.

• Communicates audit information to relevant Gilead leadership and functional areas via management reviews and quality forums.

• Assures audit program processes and tools are maintained and updated to enable consistent and successful management of audit activities.

• Partners with peer audit functions to assure knowledge sharing across GxPs

• Participates in industry forums to maintain insight into evolving trends and health authority expectations.

• Provides leadership, direction and management of audit training for R&D Quality staff. This includes working with line managers to develop staff competencies and capabilities in conduct of audits, report generation, response review and CAPA development.

• Serves as busines