Director, GCP Audits

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 R&D Quality is a phenomenal place to develop your skills and expertise. Our strong pipeline of therapies will provide you opportunities to be challenged and stretched while supported and developed by our diverse and expert team. We are a committed team of highly skilled Quality professionals dedicated to helping deliver life-saving therapies for unmet needs. We bring our passion for science, discovery, and creative thinking into everything we do.

We are an inclusive and diverse community, who are supported by strong leaders that are committed to giving each of us a voice while achieving our mission. Our collaborative and supportive structure will help you develop your skills, experience, and your career. Are you ready to explore how you can play a vital role on the team and help deliver life-saving therapies to patients around the world?

KEY RESPONSIBILITIES:

GCP Audit Program Leadership

• Accountable for the successful oversight and completion of a broad spectrum of GCP audit activities and deliverables across large sites, countries, or multiple regions.
• Lead internal and external R&D quality audits for assigned R&D groups or locations.
• Provide matrix management and leadership to project teams.
• Develop and drive continuous improvements in R&D quality processes, systems, and standards to meet regulatory requirements and organizational goals and contribute to the overall quality mindset and culture.

GCP Audit Operations

• Act as a primary point-of-contact to assigned R&D groups and advise on: GCP regulatory requirements; relevant Gilead policies and procedures supporting audits and clinical activities.  
• Evaluate SOPs, other procedures, data and reporting of assigned R&D groups / locations to ensure ongoing regulatory compliance, R&D quality and fit-for-purpose to both Gilead business needs and regulatory requirements.
• Execute the strategic audit plan. Plan, schedule, and conduct GCP audits in accordance with the audit plan.
• Prepare and deliver high quality audit reports and follow up on CAPAs to ensure timely resolution and CAPA effectiveness.  
• Lead/Support risk assessment activities, in partnership with risk program and SMEs.
• Support the overall inspection readiness of the GCP Audit program, including preparation and participation for inspections.  
• Oversee and manage the work of contractor auditors, ensuring effective oversight and completion of assigned tasks.
• Track resources and ensure compliance with regulatory timelines and quality standards for audit deliverables.
• Provide accurate and thorough input and recommendations into resource allocation and budgets.

Quality Management

• Evaluate, and advise on systems, processes, documentation, and CAPAs for assigned R&D groups to ensure ongoing compliance and alignment with regulatory requirements.
• Play a key role in preparing the assigned R&D groups for inspections or external reviews including ensuring alignment with Gilead business needs and regulatory requirements.
• Support Head of GCP/GLP Audits to implement an Effectiveness Check strategy, in partnership with GVP and E-system/Digital Audit Heads for Audit related CAPAs. 
• Stay current with evolving global clinical regulations and guidance.