Manager, Clinical Quality System Documents

Arrowhead Pharmaceuticals•San Diego, CA

6d•$120,000 - $145,000•Onsite

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops 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 mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead’s RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. 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), ensuring that clinical documentation is accurate, current, and compliant with applicable regulatory requirements, industry standards, and company procedures. Working in close partnership with Quality Management System (QMS) Quality Assurance counterparts and stakeholders across Clinical Development, the incumbent will coordinate the timely development, review, revision, approval, and retirement of Standard Operating Procedures (SOPs), work instructions, templates, and other controlled clinical documents. The Clinical Document Manager will ensure documentation remains aligned with evolving regulatory requirements, ICH guidelines, GCP standards, and applicable global health authority expectations. The incumbent will facilitate cross-functional document review workflows, monitor document lifecycle activities, and drive timely completion of document updates to support inspection readiness and operational excellence. The Clinical Document Manager will serve as a liaison between Clinical Development and Quality Assurance to ensure document consistency, harmonization, and compliance across functional areas. The incumbent will contribute to the continuous improvement of document management processes by identifying opportunities to streamline workflows, enhance document quality, and optimize the use of the organization's eQMS. The incumbent will also support the implementation of new document management capabilities, process improvements, and associated change controls. In addition, the Clinical Quality System Document Manager will provide guidance to document authors and reviewers on document standards, formatting, version control, and regulatory expectations. The role supports company inspection readiness by ensuring controlled clinical documentation is complete, current, audit-ready, and readily accessible for internal audits and regulatory inspections. The incumbent will also contribute to the development and implementation of new procedural documents, as well as updating existing documents within Arrowhead’s quality systems. The incumbent will also champion the eQMS Veeva new functionalities implementation as well as relevant change controls. The supports the company inspection readiness preparations, as well as being involved with the 3rd party inspections. This role is based in Pasadena or San Diego California, with an expectation to be in office 5 days a week.

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.

Nice To Haves

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

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 and facilitating the development, review, revision, approval, issuance, periodic review, and retirement of controlled documents across Clinical Development functions, ensuring timely completion and compliance with established document control 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 documents progress efficiently 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) and 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 applicable global regulatory requirements.
Perform other duties and special projects as assigned to support the clinical quality assurance team.