Manager, Clinical Quality System Documents

Responsibilities Serve as the primary document management lead for Clinical Development, managing the end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms, and associated documents) within the eQMS. Support QMS Quality Assurance in executing document control workflows (development, review, revision, approval, issuance, periodic review, and retirement), ensuring compliance and timeliness. Lead and coordinate document activities with cross-functional stakeholders (Clinical Operations, Drug Safety/Pharmacovigilance, Biometrics, Clinical Data Management, Clinical Development/Medical, Regulatory Affairs, Medical Writing, Clinical Supply Management, Clinical Quality Assurance). Facilitate cross-functional document review/approval workflows by coordinating authors, reviewers, approvers, and QA partners. Ensure controlled documents remain current and aligned with evolving regulatory requirements (ICH, GCP, GVP) and company policies. Monitor document status, periodic review schedules, revision timelines, and workflow metrics; communicate/escalate overdue activities. Ensure accuracy, consistency, formatting, metadata, and integrity of documents in the eQMS. Provide guidance to document authors/reviewers/approvers on standards, lifecycle processes, eQMS functionality, and regulatory expectations. Develop and communicate document management metrics/KPIs; identify process improvement opportunities. Support implementation of new document management processes, system enhancements, and related change controls. Support internal audits, regulatory inspections, and third-party audits by ensuring documentation is complete, current, inspection-ready, and retrievable. Assist with document control procedures, guidance, templates, and best practices; support inspection readiness and third-party inspections. Operate in compliance with applicable global regulatory requirements (GCP, ICH, FDA, EU Clinical Trial Regulation, and others). Requirements BS/BA in a scientific field (chemistry, biology, biochemistry, etc.). Minimum 5 years’ experience in pharma/biotech, clinical quality assurance, or CRO document writing/maintenance. Working knowledge of GCP, GVP and/or GLP. Ability to follow company procedures and policies; strong attention to detail. Ability to multi-task/prioritize with minimal supervision. Excellent interpersonal, verbal, and written communication. Preferred Experience with electronic document management systems in a regulated environment. Proficiency with Adobe Acrobat, Microsoft Word, Excel, and Smartsheet. California pay range: $120,000–$145,000 USD.This role is based in Pasadena or San Diego, California, with an expectation to be in office 5 days a week. #J-18808-Ljbffr Scorpion Therapeutics