<p>The Position</p> <p>The Manager, Quality Engineering will work within the Quality organization to manage and lead activities supporting equipment and facility commissioning/qualification/validation (CQV) for GMP manufacturing and GLP/GMP testing. This position also will have quality oversight of process development and the process lifecycle, including validation and annual drug product review. The incumbent will manage the Quality functions involved with the CQV program, including drafting new procedures and updating existing documents within Arrowhead's quality systems. The role will work to ensure Arrowhead's systems and procedures meet current industry expectations for CQV in clinical and commercial GMP drug substance manufacturing and GLP/GMP testing facilities.</p> <p>Responsibilities</p> <ul> <li>Prepare, update, review, and route Arrowhead procedural documents (such as Policies, SOPs, Work Instructions, Forms, protocols, and Test Methods) utilizing existing templates. </li><li>Interact with representatives from other departments, including Manufacturing, Facility Engineering & Automation, Analytical Development, QC, BioA/DMPK, and Facilities, to obtain the necessary information and details for upcoming equipment needs including installation and maintenance of equipment. </li><li>Work with system owners and end users to identify system requirements for validation and intended use definition. </li><li>Review and approval of internal and vendor-generated documentation, including, but not limited to, validation master plans, qualification protocols, User Requirements Specification, System Impact Assessments, executed documentation, and final reports. </li><li>Upload documents to Arrowhead's EDMS, Veeva QualityDocs, and route for electronic approval. </li><li>Initiate, review, and approve change controls as necessary within the EDMS and equipment/facility change control areas within the EDMS/QMS as necessary. </li><li>Enter and/or approve documents and equipment/instrument data into tracking software system (such as Blue Mountain Regulatory Asset Manager). </li><li>Provide Quality department support for the metrology program, including calibration frequency planning, procedures, vendor interactions, and review of data/reports. </li><li>Interact with other departments involved with facility and equipment cleaning verification/validation procedures and activities. </li><li>Participate in evaluating, documenting, and tracking deviations/CAPAs pertaining to CQV and metrology activities. </li><li>Develop and manage plans and procedures for periodic evaluation and re-execution of CQV for instruments, equipment, and facilities. </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's degree in an applicable science field. </li><li>Additional Quality related certification desired, CQA, CQMP </li><li>8 years of experience in a pharmaceutical/biotech company, contract manufacturing organization, or contract research organization with expanding responsibilities in the area of equipment and/or instrument qualification. </li><li>3 years working in a commercial GMP manufacturing facility with execution of CQV. </li><li>Working knowledge of overall GMP and/or GLP regulations. </li></ul> <p>Preferred</p> <ul> <li>Advanced degree </li><li>Prior experience with use of an electronic document management system in a regulated environment </li><li>Additional Quality related certification desired, CQA, CQMP </li></ul>