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Pasadena, California, United States • On-site
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Manage the end-to-end lifecycle of controlled clinical quality documents within the eQMS to ensure regulatory compliance and inspection readiness. Act as a liaison between Clinical Development and Quality Assurance to harmonize documentation and streamline workflows.
Requires a BS/BA in a scientific field and at least 5 years of experience in pharmaceutical/biotech document maintenance. Must have working knowledge of GCP, GVP, or GLP regulations and proficiency in document management tools.
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
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
At Arrowhead Pharmaceuticals we are breaking the mold of medicine. We are pushing the boundaries of therapeutic development and revolutionizing how we care for hard-to-treat illnesses. As a company we harness collaboration and innovation to rapidly advance drugs from discovery to the clinic. All applicants: Please be aware of employment scams using Arrowhead’s name and the names of Arrowhead’s employees. All job related Arrowhead communication should come from the domain @arrowheadpharma.com.
Offices: 177 E Colorado Blvd, Suite 700, Pasadena, California 91105, US · 502 S Rosa Rd, Madison, Wisconsin 53719, US · 10102 Hoyt Park Drive, San Diego, CA 92131, US · 1080 Arrowhead Way, Verona, WI 53593, US
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