Quality Systems Specialist

Role: Support and enhance the Quality Management System (QMS) at Takeda's Thousand Oaks site as a Quality Systems Specialist. Responsibilities: oversee key QMS processes such as Change Controls, Deviations, CAPAs, Document Control, and Supplier Quality; review and approve quality documentation; develop and update SOPs; facilitate cross-functional quality training; maintain dashboards and report performance trends; support system administration and process improvements; assist in audit and inspection readiness, and collaborate across departments to promote compliance and a strong quality culture. Requirements: Bachelor's in Science, Engineering, or related field; at least 5 years of quality experience in regulated environments, with functional knowledge of nonconformance management, change control, CAPA, and document systems; understanding of global cGMP regulations; strong project management, communication, and analytical skills; proficiency in Excel and familiarity with electronic QMS tools. Preferred: experience supporting audits, working with Quality System process improvements, and serving as a system administrator. HighValue: focus on pharmaceutical/biotech manufacturing operations, compliance, and continuous improvement initiatives within a regulated environment. Work setup: primarily office-based with schedule flexibility and potential for extended hours to support audits and operational needs.