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Senior Specialist, Quality Systems (Change Control)

United States - California - Santa Monica, United States - Maryland - FrederickQualityRegular

Job Description (Translated)

Kite is a cell therapy company that is focused on providing patients with highly effective, life-saving therapies.  We have two commercial products, Yescarta® and Tecartus®, along with a robust pipeline of various autologous and allogeneic clinical programs.   We are seeking a highly motivated individual to join us as Sr. Specialist, Quality Systems. This role reports into the Sr. Director, Quality Systems at our corporate headquarters location in Santa Monica and will be a member of our new Global Change Control Team with a primary focus of providing support for global change controls.  In this role you will interface and build strong partnerships with other parts of the global organization as well as the Corporate Quality Systems Team. You will support a multi-disciplinary team responsible for managing elements of the Quality Management System (QMS) including Deviations, CAPA, Change Management, Training, Document Control, Quality Risk Management, and Management Review. your role will be to support the change management process with specific focus on global change controls. Responsibilities: Support activities and lead efforts related to maintaining a state of control and continuously improving the QMS. Develop, implement, and maintain procedures, business enabling guidance, work instructions, and forms to support and mature the global programs in support of the Kite QMS. Support Global initiatives and projects.   Advise Corporate Functions and Kite Commercial Sites on the interpretation and execution of QMS procedures. Deliver training for Corporate Functions and assist sites as training host, or co-host. Complete metric reports and metric follow-up actions including the monitoring of Corporate Functions to ensure compliance to procedures in support of biweekly Tier huddles and Quarterly Management Reviews. Create analytical reports for metric reporting and trending. Assist in development of training materials for various elements of the QMS. Own, process, or approve quality management system records such as Audit, Deviation, CAPA, EV, with a primary focus on Change Controls and associated quality records. Support regulatory inspections and internal audits. Basic Qualifications: Master’s Degree and 4+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations OR Bachelor’s Degree and 6+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations OR High School Degree and 10+ years’ experience in Quality and/or Manufacturing within pharmaceutical, biotech, biologics, and/or cell therapy operations Preferred Qualifications: Previous practical experience with management of change controls on a global level. Experience with processing other types of quality records such as Deviations, CAPA, and effectiveness checks/verifications if desired. Subject matter level expertise (SME) in Change Control/Management, and CAPA Knowledge and understanding of global regulations specific to Quality Systems. Previous experience in data analysis, metric creation, and reporting. Previous experience in leading training and presenting to staff of all levels. Comfortable interacting with regulatory agencies. Familiar with aseptic manufacturing and/or cell therapy processes. Previous experience leading cross-functional projects. Six Sigma or LEAN training Strong knowledge of GMPs Advanced Skills with MS Office applications Word, Excel, Access, and Adobe Acrobat. Ability to communicate and work independently with scientific/technical personnel. Self-starter that is results oriented, strives for continuous improvement, and possesses excellent written, verbal communication, and critical thinking skills. #QCQA123 #IND123