Sr Specialist, Quality Systems

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
 

Job Responsibilities:

• Independently and proactively initiate and drive the planning, execution, and completion of change management projects

• Develop and implement strategies to mitigate risks within the change management process and change control system.

• Facilitate and present at cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS and regulatory expectations.  

• Responsible for managing change controls related to manufacturing product, process, equipment, facility, and computerized systems contributing to the oversight of key strategic, tactical, and operational goals.

• Develop, deliver, and improve the change management program for various levels of the organization, while also ensuring training effectiveness.

• Independently review, initiate, complete, and thoroughly document critical, major, and minor change controls, managing local and global change controls and associated activities related to GxP operations.

• Navigate through complex change review discussions, facilitating to a common decision for each change regarding approach and follow-up actions to be taken, and documenting the decisions and evaluations accordingly.

• Supports management and monitoring of change records for adherence to organizational or departmental metric targets, and maintenance of associated tracking tools/databases.

• Supports management review process through development and generation of quality system metrics and trending, and escalates issues as required.  In-depth evaluation will be needed.

• Work closely with Change Management Business Process Lead and business support team members to support enhancements of the change control QMS processes and business process.

• Supports the maintenance and improvement of quality systems processes, as needed. 

• Works directly with operating entities and internal clients to ensure follow-up of change tasks.  

• Participate in compliance audits as required.  

• Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (cGMPs).

• Writes and/or implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Provides guidance and technical knowledge to more junior staff, monitors the performance of daily tasks.

Knowledge:

• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards, particularly related to change management.

• Demonstrates ability to effectively manage multiple complex projects and priorities simultaneously.

• Demonstrates ability to work independently

• Has proven analytical and conceptual skills. Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.

• Demonstrates excellent verbal communication, technical writing and interpersonal skills.

• Experience in Qu