Manager, Clinical Quality System Documents

Role: Clinical Quality System Document Manager overseeing the control and maintenance of clinical quality documents within the eQMS for Arrowhead's clinical development functions. Responsibilities: manage end-to-end document lifecycle for SOPs, work instructions, and templates; coordinate with cross-functional teams including Clinical Operations, Data Management, and QA; ensure documents align with GxP, GCP, ICH, and regulatory standards; monitor document workflows, review statuses, and metrics; support inspection readiness and continuous improvement of document processes; provide guidance on document standards and facilitate system enhancements. Requirements: BS/BA in a scientific field; 5+ years in pharma/biotech, clinical QA, or CRO with experience in document management; knowledge of GCP, GVP, GLP; strong organizational and communication skills; familiarity with electronic document management systems preferred. HighValue: focus on clinical documentation in regulated environments, supporting compliance during audits and inspections, with an emphasis on GCP standards and global regulatory alignment. WorkSetup: based in Pasadena or San Diego, CA, in-office five days a week.