Manager, Clinical Quality System Documents
Arrowhead Pharmaceuticals
August 30, 2026
On-site
San Diego, CA
Operations
Responsibilities:
- Serve as primary document management lead for Clinical Development, managing end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms) in the eQMS.
- Support QMS Quality Assurance in document control workflows: development, review, revision, approval, issuance, periodic review, and retirement of controlled documents.
- Lead 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) to ensure timely deliverables.
- Facilitate cross-functional review/approval workflows and coordinate authors, reviewers, approvers, and QA partners.
- Ensure documents remain current and aligned with evolving regulatory requirements (ICH, GCP, GVP) and company policies.
- Monitor document status, review schedules, timelines, and workflow metrics; communicate/escalate overdue activities.
- Ensure accuracy, consistency, formatting, metadata, and integrity of eQMS documents.
- Provide guidance on document standards, lifecycle processes, eQMS functionality, and regulatory expectations.
- Develop KPIs/metrics for inspection readiness and continuous improvement.
- Support implementation of document management process enhancements and change controls.
- Support internal, regulatory, and third-party audits by ensuring documents are complete, current, inspection-ready, and retrievable.
- Assist with development/revision of document control procedures, guidance, templates, and best practices.
- Support company compliance with applicable global regulatory requirements (GCP, ICH, FDA, EU Clinical Trial Regulation).
Requirements:
- BS/BA in a scientific field (chemistry, biology, or biochemistry).
- 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/policies.
- Excellent attention to detail, organization, and communication.
- Ability to multi-task/prioritize with minimal supervision.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Competent knowledge of Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.
- Serve as primary document management lead for Clinical Development, managing end-to-end lifecycle of controlled clinical documents (SOPs, work instructions, templates, forms) in the eQMS.
- Support QMS Quality Assurance in document control workflows: development, review, revision, approval, issuance, periodic review, and retirement of controlled documents.
- Lead 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) to ensure timely deliverables.
- Facilitate cross-functional review/approval workflows and coordinate authors, reviewers, approvers, and QA partners.
- Ensure documents remain current and aligned with evolving regulatory requirements (ICH, GCP, GVP) and company policies.
- Monitor document status, review schedules, timelines, and workflow metrics; communicate/escalate overdue activities.
- Ensure accuracy, consistency, formatting, metadata, and integrity of eQMS documents.
- Provide guidance on document standards, lifecycle processes, eQMS functionality, and regulatory expectations.
- Develop KPIs/metrics for inspection readiness and continuous improvement.
- Support implementation of document management process enhancements and change controls.
- Support internal, regulatory, and third-party audits by ensuring documents are complete, current, inspection-ready, and retrievable.
- Assist with development/revision of document control procedures, guidance, templates, and best practices.
- Support company compliance with applicable global regulatory requirements (GCP, ICH, FDA, EU Clinical Trial Regulation).
Requirements:
- BS/BA in a scientific field (chemistry, biology, or biochemistry).
- 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/policies.
- Excellent attention to detail, organization, and communication.
- Ability to multi-task/prioritize with minimal supervision.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Competent knowledge of Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.
Application instructions:
- Candidates must have current, valid authorization to work in the country where this role is located.