Gilead Sciences, Inc.
Sr Specialist, Quality Systems
Gilead Sciences, Inc., Foster City, California, United States, 94420
* 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.* 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 Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)* Demonstrates strong proficiency in Microsoft Office applications.* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. #J-18808-Ljbffr
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.* 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 Quality Management System (i.e Veeva, TrackWise, MasterControl, etc)* Demonstrates strong proficiency in Microsoft Office applications.* Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.* Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.* Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. #J-18808-Ljbffr