Manager, Clinical Quality System Documents

About the role

Arrowhead Pharmaceuticals is a commercial-stage biopharmaceutical company developing RNAi-based medicines that silence genes causing intractable diseases. The Clinical Quality System Document Manager will oversee clinical quality documents within the electronic Quality Management System (eQMS), ensuring accuracy, currency, and compliance with regulatory requirements, ICH guidelines, GCP standards, and global health authority expectations. The role partners closely with Quality Assurance and cross-functional stakeholders to manage SOPs, work instructions, templates, and controlled documents, supporting inspection readiness and operational excellence.

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) within the eQMS.
• Coordinate with QMS Quality Assurance to facilitate development, review, revision, approval, issuance, periodic review, and retirement of controlled documents across Clinical Development functions.
• Lead document activities with cross-functional stakeholders including Clinical Operations, Drug Safety/Pharmacovigilance, Biometrics, Clinical Data Management, Clinical Development/Medical, Regulatory Affairs, Medical Writing, Clinical Supply Management, and Clinical Quality Assurance.
• Facilitate cross-functional document review and approval workflows by coordinating authors, reviewers, approvers, and QA partners to ensure efficient progression through review and approval.
• Ensure controlled documents remain current and aligned with evolving regulatory requirements, ICH guidelines, GCP, GVP, and company policies.
• Monitor document status, periodic review schedules, revision timelines, and workflow metrics; escalate overdue activities as needed.
• Ensure accuracy, consistency, formatting, metadata, and integrity of controlled clinical documents in the eQMS.
• Provide guidance to document authors, reviewers, and approvers on document standards, lifecycle processes, eQMS functionality, and regulatory expectations.
• Develop, generate, analyze, and communicate document management metrics and KPIs to support management review, process monitoring, inspection readiness, and continuous improvement.
• Identify process improvement opportunities by streamlining workflows, standardizing documentation practices, and enhancing collaboration between Clinical Development and Quality Assurance.
• Support implementation of new document management processes, system enhancements, and change controls related to the Clinical Quality Management System and eQMS.
• Support internal audits, regulatory inspections, and third-party audits by ensuring controlled clinical documentation is complete, current, inspection-ready, and retrievable.
• Assist in the development, revision, and maintenance of document control procedures, guidance documents, templates, and best practices supporting an effective Clinical Quality Management System.
• Champion eQMS Veeva new functionalities implementation and relevant change controls.
• Foster cross-functional partnerships and promote a culture of quality, compliance, accountability, and continuous improvement.
• Operate in compliance with applicable global regulatory requirements including GCP, ICH guidelines, FDA regulations, and EU Clinical Trial Regulation.

Requirements

• BS/BA in a scientific field such as chemistry, biology, or biochemistry.
• Minimum of 5 years of experience in a pharmaceutical/biotech company, clinical quality assurance, or CRO, with a focus on writing and maintaining documents.
• Working knowledge of GCP, GVP, and/or GLP regulations.
• Ability to follow company procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.

Preferred

• Prior experience with use of an electronic document management system in a regulated environment.
• Competent knowledge of Adobe Acrobat, Microsoft Word, Excel, and Smartsheet.

Pay

California pay range: $120,000 USD – $145,000 USD