Manager, Clinical Quality System Documents

Role: Clinical Quality System Document Manager overseeing clinical quality documentation within the electronic Quality Management System (eQMS) to ensure regulatory compliance, accuracy, and inspection readiness. Responsibilities: manage the end-to-end lifecycle of controlled clinical documents including SOPs, work instructions, and templates; facilitate cross-functional review workflows; monitor document status and timelines; support process improvements and system enhancements; assist in audits and inspections; and guide document authors on standards and regulatory expectations. Requirements: BS/BA in a scientific field; 5+ years in pharmaceutical or biotech industry related to clinical document management, quality assurance, or CROs; knowledge of GCP, GVP, GLP regulations; strong organizational, communication, and multitasking skills. Preferred qualifications include experience with electronic document management systems, proficiency in Adobe Acrobat, Microsoft Word, Excel, and Smartsheet. High-value specifics: role in a clinical development environment, supporting GCP compliance, with focus on document control for clinical trials. Location: Pasadena or San Diego, CA; in-office 5 days per week.