Manager, Clinical Quality System Documents

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a natural cellular process that inhibits the expression of specific genes, thereby affecting the production of specific proteins. Arrowhead’s RNAi-based therapeutics leverage this pathway to address diseases with a genetic basis, typically characterized by the overproduction of disease-related proteins. The company’s RNAi technologies enable the potential treatment of conditions across virtually any therapeutic area, including targets not addressable by small molecules and biologics. Arrowhead leads the field in advancing RNAi therapies beyond the liver, with a clinical pipeline targeting diseases in the liver and lung, and a robust preclinical pipeline. Headquartered in Pasadena, CA, Arrowhead has research and development teams in Madison, WI, and San Diego, CA, and a state-of-the-art manufacturing facility in Verona, WI.

About the role

The Clinical Quality System Document Manager is responsible for the management, maintenance, and oversight of clinical quality documents within the electronic Quality Management System (eQMS). This role ensures clinical documentation is accurate, current, and compliant with regulatory requirements, industry standards, and company procedures. Working closely with Quality Management System (QMS) Quality Assurance counterparts and stakeholders across Clinical Development, the incumbent coordinates the development, review, revision, approval, and retirement of Standard Operating Procedures (SOPs), work instructions, templates, and other controlled clinical documents. The role ensures alignment with evolving regulatory requirements, ICH guidelines, GCP standards, and global health authority expectations. The incumbent facilitates cross-functional document review workflows, monitors document lifecycle activities, and drives timely updates to support inspection readiness and operational excellence. Additionally, the role serves as a liaison between Clinical Development and Quality Assurance to ensure document consistency, harmonization, and compliance. The Clinical Quality System Document Manager contributes to continuous improvement of document management processes, supports the implementation of new eQMS capabilities, and provides guidance to document authors and reviewers on standards, formatting, version control, and regulatory expectations.

Responsibilities

• Serve as the primary document management lead for Clinical Development, driving and facilitating the end-to-end lifecycle of controlled clinical documents, including Standard Operating Procedures (SOPs), work instructions, templates, forms, and associated documents within the electronic Quality Management System (eQMS).
• Support QMS Quality Assurance (QA) counterparts in executing document control workflows by coordinating the development, review, revision, approval, issuance, periodic review, and retirement of controlled documents across Clinical Development functions, ensuring timely completion and compliance with established processes.
• Lead and coordinate document activities with cross-functional business 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, ensuring timely completion of document deliverables.
• Facilitate cross-functional document review and approval workflows by coordinating authors, reviewers, approvers, and QA partners to ensure efficient progression through the review and approval process.
• Collaborate with Clinical Development functional representatives and QMS QA to ensure controlled documents remain current and aligned with evolving regulatory requirements, ICH guidelines, Good Clinical Practice (GCP), Good Pharmacovigilance Practices (GVP), and company policies.
• Monitor document status, periodic review schedules, revision timelines, and workflow metrics, proactively communicating and escalating overdue document activities to functional management and Quality Assurance, as appropriate.
• Ensure the accuracy, consistency, formatting, metadata, and integrity of controlled clinical documents maintained within the eQMS.
• Provide guidance and support to document authors, reviewers, and approvers regarding document standards, document lifecycle processes, eQMS functionality, and regulatory expectations.
• Develop, generate, analyze, and communicate document management metrics and Key Performance Indicators (KPIs) to support management review, process monitoring, inspection readiness, and continuous improvement initiatives.
• Identify opportunities to improve document management processes by streamlining workflows, standardizing documentation practices, and enhancing collaboration between Clinical Development and Quality Assurance.
• Support the 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 readily retrievable.
• Assist in the development, revision, and maintenance of document control procedures, guidance documents, templates, and best practices that support an effective Clinical Quality Management System.
• Foster strong cross-functional partnerships and promote a culture of quality, compliance, accountability, and continuous improvement throughout Clinical Development.
• Operate in compliance with applicable global regulatory requirements, including Good Clinical Practice (GCP), ICH guidelines, FDA regulations, EU Clinical Trial Regulation, and other global regulatory expectations.
• Perform other duties and special projects as assigned to support the clinical quality assurance team.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• Minimum of 5 years of experience in a pharmaceutical/biotech company, clinical quality assurance, or contract research organization 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 Qualifications

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

Pay

California pay range: $120,000 USD - $145,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Schedule

This role is based in Pasadena or San Diego, California, with an expectation to be in office 5 days a week.