Manager, Clinical Quality System Documents

Clinical Quality System Document Manager (Pasadena or San Diego, CA; in office 5 days/week)

• Manage, maintain, and oversee clinical quality documents in the eQMS; ensure accuracy, currency, and compliance with regulatory/industry/company requirements.
• Coordinate end-to-end lifecycle of controlled documents (SOPs, work instructions, templates, forms) including development, review, revision, approval, issuance, periodic review, and retirement.
• Facilitate cross-functional document review workflows and monitor document status, timelines, and metrics; escalations overdue items.
• Partner with QMS Quality Assurance to ensure harmonization and consistency across Clinical Development functions.
• Provide guidance to document authors/reviewers on standards, formatting, version control, and regulatory expectations.
• Support inspection readiness (internal, regulatory, and third-party) by ensuring documentation is complete, audit-ready, and retrievable.
• Develop/maintain document control procedures and contribute to continuous improvement of document management processes and eQMS (Veeva) enhancements/change controls.

• BS/BA in a scientific field (e.g., chemistry, biology, biochemistry).
• 5+ years in pharma/biotech, clinical quality assurance, or CRO document writing/maintenance.
• Working knowledge of GCP, GVP and/or GLP.
• Ability to follow company procedures/policies.
• Strong attention to detail, organization, prioritization, and communication.

• Experience with electronic document management systems in regulated environments.
• Proficiency with Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.

• $120,000-$145,000 USD.