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).

• 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.

• 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.