Manager, Clinical Quality System Documents
Arrowhead Pharmaceuticals
August 08, 2026
On-site
San Diego, CA
Operations
Clinical Quality System Document Manager (Pasadena or San Diego, CA; in office 5 days/week)
Responsibilities:
- 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; escalate 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.
Requirements:
- 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.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Proficiency with Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.
Pay range: $120,000–$145,000 USD.
Application instruction: Must have current, valid authorization to work in the role’s location country.
Responsibilities:
- 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; escalate 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.
Requirements:
- 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.
Preferred:
- Experience with electronic document management systems in regulated environments.
- Proficiency with Adobe Acrobat, Microsoft Word/Excel, and Smartsheet.
Pay range: $120,000–$145,000 USD.
Application instruction: Must have current, valid authorization to work in the role’s location country.