<p>The Position</p> <p>The purpose of this position is to provide quality assurance support to programs utilizing contract development, manufacturing, and testing organizations. This role is part of a team that oversees all aspects of supplier quality. This person will be expected to interact with contract organizations as well as internal departments to support ongoing pre-clinical and clinical development as well as commercial programs at Arrowhead Pharmaceuticals, Inc.</p> <p>Responsibilities</p> <ul> <li>Complete requests for supplier documentation in support of supplier maintenance activities. </li><li>Perform quality agreement lifecycle management, including but not limited to, drafting, editing, reviewing, approving, and ensuring compliance with periodic review cycles. </li><li>Review, approve, categorize, and maintain supplier documentation, including but not limited to, questionnaires, registration documents, accreditations, certifications, BSE/TSE statements, etc. </li><li>Collaborate with QA teammates and supplier quality assurance representatives on supplier quality events and non-conformances as outlined in the applicable quality agreements. </li><li>Capture supplier quality data and generate metrics. </li><li>Scan and upload documents to the EDMS, properly categorize within the system, and route for verification/approval. </li><li>Assist with preparation, update, review, and routing of Arrowhead procedural documents. </li><li>Assist with QA duties as needed. </li></ul> <p>Requirements:</p> <ul> <li>BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry is preferred </li><li>8 years of quality assurance experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization. </li><li>Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents. </li><li>Prior experience with use of an electronic document management system in a regulated environment. </li><li>Competent knowledge of and ability to use Adobe Acrobat, Microsoft Office programs, DocuSign, and SmartSheet. </li><li>Excellent interpersonal, verbal, and written communication skills. </li><li>Ability to consistently communicate with external parties in a professional manner. </li><li>Ability to follow company procedures, work instructions, and policies. </li><li>Excellent attention to detail and organizational skills. </li><li>Ability to work independently with minimal supervision as well as manage priorities within a face paced environment. </li></ul>