Sr Manager, Quality Systems

Job Description

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.

Quality Assurance delivers on Gilead’s commitment to bring life‑changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life‑changing therapies.

As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on‑going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late‑stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life‑threatening diseases.

Meet the worldwide QA Team: https://qualit

• Supports, facilitates and adapts the Gilead Quality Management System related to computerized system lifecycle management to ensure that it meets regulatory and industry standards and expectations.
• Identifies and onboards qualified external resources to support project demand.
• Provides expert guidance on topics related to computer system compliance to regulatory requirements.
• Identifies opportunities for, and leads implementation of projects that drive the continued improvement of Gilead’s quality management processes related to management of computerized systems.
• Ensures that technical, business and QA teams are prepared for regulatory inspections related to computerized systems.
• Provides oversight and QA approvals for GxP Deviations, CAPAs and change controls to ensure activities are conducted in compliance with Gilead procedures and regulatory requirements.
• Authors or approves procedures, work instructions and other governing documents to support Gilead’s computerized system lifecycle.
• Reviews and approves validation deliverables for medium‑to large‑sized projects.

• Performs a wide variety of activities to ensure compliance with GxP Laboratory systems, quality procedures and applicable regulatory requirements.
• Manages QA personnel, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.

• Bachelor’s degree and 8+ years of relevant experience; OR
• Masters’ degree and 6+ years of relevant experience; OR
• PhD and 2+ years of relevant experience

• Demonstrates in‑depth knowledge of Good Manufacturing Practices (GMPs).
• Demonstrates in‑depth knowledge of QA systems principles, concepts, industry practices, and standards.
• Demonstrates excellent verbal, written, and interpersonal communication skills.
• Keen understanding of international…