Sr. Specialist, Quality Systems- Change Control

For Current Gilead Employees and Contractors:

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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
 

Job Responsibilities:

• 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.. 
• 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. m
• Facilitate cross-functional meetings with stakeholders and leadership to ensure alignment with proposed changes and compliance to QMS expectations.  
• 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.  
• 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 & Skills:

• Will need to demonstrate the ability to manage multiple change controls of varying complexity and scope of tasks in a fast-paced environment to meet timelines.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) 
• Demonstrates proficiency in application of QA systems principles, concepts, industry practices, and standards.
• Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.
• Demonstrates Project Management abilities to lead and manage several projects, meeting deadlines and use critical thinking skills to problem solve effectively.
• Demonstrate strong scientific/technical understanding of small and/or large biologic molecule operations and related regulations/guidelines.
• Demonstrates knowled