Manager, Clinical Quality System Documents
Arrowhead Pharmaceuticals
August 29, 2026
On-site
Los Angeles, CA
Operations
The Clinical Quality System Document Manager is responsible for managing, maintaining, and overseeing clinical quality documents within the electronic Quality Management System (eQMS) to ensure accuracy, currency, and compliance with regulatory requirements, industry standards, and company procedures.
Responsibilities:
- Manage end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms) within eQMS.
- Coordinate document control workflows with QMS Quality Assurance: development, review, revision, approval, issuance, periodic review, and retirement.
- Lead cross-functional document activities with stakeholders across Clinical Development, QA, and other clinical functions.
- Facilitate cross-functional review/approval workflows for efficient document progression.
- Ensure documents remain current and aligned with evolving requirements (ICH, GCP, GVP, company policies).
- Monitor document status/review schedules, timelines, and metrics; communicate/escalate overdue items.
- Ensure document accuracy, consistency, formatting, metadata, and integrity in eQMS.
- Provide guidance to document authors/reviewers on standards, formatting, version control, and expectations.
- Develop and communicate document management KPIs/metrics for inspection readiness and continuous improvement.
- Support implementation of new document management capabilities and change controls.
- Support internal audits, regulatory inspections, and third-party audits by ensuring documentation is complete, current, and retrievable.
Requirements:
- BS/BA in chemistry, biology, or biochemistry (or applicable scientific field).
- 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 and policies; strong attention to detail and organizational skills.
- Ability to multitask/prioritize with minimal supervision; strong verbal/written communication.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Knowledge of Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.
Responsibilities:
- Manage end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms) within eQMS.
- Coordinate document control workflows with QMS Quality Assurance: development, review, revision, approval, issuance, periodic review, and retirement.
- Lead cross-functional document activities with stakeholders across Clinical Development, QA, and other clinical functions.
- Facilitate cross-functional review/approval workflows for efficient document progression.
- Ensure documents remain current and aligned with evolving requirements (ICH, GCP, GVP, company policies).
- Monitor document status/review schedules, timelines, and metrics; communicate/escalate overdue items.
- Ensure document accuracy, consistency, formatting, metadata, and integrity in eQMS.
- Provide guidance to document authors/reviewers on standards, formatting, version control, and expectations.
- Develop and communicate document management KPIs/metrics for inspection readiness and continuous improvement.
- Support implementation of new document management capabilities and change controls.
- Support internal audits, regulatory inspections, and third-party audits by ensuring documentation is complete, current, and retrievable.
Requirements:
- BS/BA in chemistry, biology, or biochemistry (or applicable scientific field).
- 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 and policies; strong attention to detail and organizational skills.
- Ability to multitask/prioritize with minimal supervision; strong verbal/written communication.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Knowledge of Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.