<p>The Position</p> <p>The purpose of this position within the Quality Assurance department is to support on-going development programs for clinical and commercial drug candidates at Arrowhead. A key function of the position will involve quality oversight functions for external organizations. The candidate will be expected to interact with multiple internal departments and external vendors. The role will involve leadership and development of QA department staff.</p> <p>Responsibilities</p> <ul> <li>Management, hiring, and mentoring of QA department staff. </li><li>Participate in meetings with vendors and external organizations as the QA representative. </li><li>Collaborate with, and provide quality support for, other departments (CMC, Project Management, Toxicology, Clinical Operations, Supply etc.). </li><li>Organization and control of quality, compliance, and project related </li><li>Review and approval of internal and vendor generated documentation, including master batch records, executed batch records, labels, certificates, reports, and testing </li><li>Monitoring of clinical temperature excursions. </li><li>Auditing of vendor and internal documentation and quality </li><li>Maintain knowledge of current compliance expectations and regulations pertaining to drug development. </li><li>Write, review, update, approve, issue, and organize applicable Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ). </li><li>Other duties consistent with the position as assigned from time to time. </li></ul> <p>Requirements:</p> <ul> <li>Bachelor's in Chemistry (or related field) with 6+ years of relevant experience </li><li>Excellent communication skills and ability to work with diverse </li><li>Highly motivated team player willing to contribute to a growing pharmaceutical </li><li>A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at </li><li>Experience with development, implementation, and maintaining compliance systems and procedures. </li><li>Demonstrated leadership of projects and/or personnel for completion of assigned </li></ul> <p>Preferred:</p> <ul> <li>Advanced degree </li><li>Previous management experience preferred. </li><li>Additional Quality/Regulatory related certification desired, such as CQA, CQMP, RAC, </li></ul>