Vice President, Quality

<div class="content-intro"><p>Arrowhead Pharmaceuticals, Inc. (Nasdaq:&nbsp; ARWR) is a clinical 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.</p> <p>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.</p> <p>Arrowhead’s corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI &amp; San Diego, CA, and a state of the art manufacturing facility in Verona, WI.&nbsp; Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.&nbsp;</p></div><p><strong>The Position</strong></p> <p>The Vice President, Quality serves a pivotal role in providing quality leadership and guidance to all corporate functional areas. The position is responsible for the design, implementation, and oversight of all GxP quality procedures and Quality Systems.&nbsp; The role is responsible for a wide variety of activities to ensure compliance with regulatory requirements that involves oversight of internal activities and resources as well as external vendors.</p> <p>This position has oversight of both Quality Assurance groups as well as the Quality Control laboratory function within the organization.</p> <p><em>Responsibilities</em></p> <ul> <li>Develop and&nbsp;facilitate&nbsp;Quality Systems as delineated in the Quality Manual&nbsp;to support Arrowhead’s clinical development pipeline and preparations for&nbsp;product commercialization&nbsp;</li> <li>Implement and&nbsp;maintain&nbsp;an overall&nbsp;Quality&nbsp;Management&nbsp;System&nbsp;(QMS)&nbsp;meeting the requirements of activities&nbsp;conducted&nbsp;within Arrowhead&nbsp;</li> <li>Develop&nbsp;and oversee&nbsp;the internal Quality Control (QC) lab department and operations&nbsp;</li> <li>Support activities relating to&nbsp;clinical QA&nbsp;GCP regulations at the Pasadena location&nbsp;</li> <li>Ensure systems are in place for conducting and tracking employee training required&nbsp;by&nbsp;GxP&nbsp;regulations&nbsp;</li> <li>Support&nbsp;efforts&nbsp;pertaining to&nbsp;internal design, construction, commissioning, and qualification of GMP facilities&nbsp;</li> <li>Review and approve&nbsp;outsourced&nbsp;contract manufacturing documentation such as validation protocols and reports;&nbsp;master&nbsp;batch records;&nbsp;deviations;&nbsp;analytical&nbsp;methods and methods validation; executed batch documentation; labels; and packaging records&nbsp;</li> <li>Maintain a system for qualification of GxP vendors and coordinate&nbsp;auditing of&nbsp;GxP&nbsp;vendors&nbsp;</li> <li>Ensure an system for GXP vendor qualification&nbsp;</li> <li>Establish Quality Agreements with GMP vendors&nbsp;</li> <li>Lead development and maintenance of service and supplier vendor qualification programs&nbsp;</li> <li>Perform investigations into non-conformances and product deviations&nbsp;</li> <li>Document and&nbsp;determine&nbsp;CAPAs, change controls&nbsp;required&nbsp;for internal cGMP processes as well as oversight of these investigations and corrective actions with external vendors&nbsp;</li> <li>Implement and&nbsp;maintain&nbsp;a validated document control system,&nbsp;and develop SOPs/Work Instructions (WI)&nbsp;across functional areas&nbsp;impacting&nbsp;GMP, GLP,&nbsp;and&nbsp;GCP&nbsp;</li> <li>Lead communication and interaction with Qualified Person (QP) to support investigational and commercial product supply chain in Europe&nbsp;</li> <li>Participate in hosting audits or inspections of Arrowhead’s QMS by regulatory agencies,&nbsp;development&nbsp;partners&nbsp;and licensees&nbsp;</li> <li>Participate in the established review cycle of QA controlled documents and GxP procedures to assure practices reflect written procedures&nbsp;</li> <li>Keep supervisor abreast of significant issues or developments&nbsp;identified&nbsp;during quality activities, as well as actions&nbsp;to be&nbsp;taken for&nbsp;continuous&nbsp;improvement&nbsp;of quality systems&nbsp;</li> <li>Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to&nbsp;GxP&nbsp;regulations&nbsp;</li> <li>Participate in the establishment and maintenance of&nbsp;an&nbsp;internal&nbsp;system for&nbsp;documentation organization and retention that meets&nbsp;global&nbsp;regulatory requirements and corporate business needs&nbsp;</li> <li>Lead the&nbsp;annual management review of the overall Quality Management System and associated data&nbsp;</li> <li>Hiring, development, and leadership of&nbsp;Quality&nbsp;department staff&nbsp;</li> </ul> <p><strong>Requirements</strong></p> <ul> <li>BS in Life Sciences or related discipline</li> <li>15+ years in QA or compliance with particular experience in cGMP commercial manufacturing environment and with experience in GCP clinical programs for drugs and/or biologics preferred&nbsp;</li> <li>10+ years in&nbsp;a previous&nbsp;management role&nbsp;</li> <li>Experience with developing a QMS and hosting successful regulatory agency inspections&nbsp;</li> <li>Ability to thrive in a&nbsp;fast-paced&nbsp;environment, with experience in sponsor quality oversight responsibilities for contract vendors across&nbsp;all&nbsp;GxP&nbsp;areas&nbsp;</li> <li>Implementation of&nbsp;internal phase&nbsp;appropriate GMP&nbsp;drug substance manufacturing &amp; testing systems&nbsp;</li> <li>Prior successful management of a Quality Management System for commercial product</li> <li>Drug development through&nbsp;commercial manufacturing compliance experience&nbsp;</li> <li>Excellent oral and written communication skills&nbsp;required&nbsp;</li> <li>Strong computer skills&nbsp;utilizing&nbsp;a Microsoft environment (e.g.&nbsp;Word, Excel, Access, PowerPoint)&nbsp;</li> <li>Familiarity with electronic document managements systems, Part 11&nbsp;compliance&nbsp;and electronic document archiving systems&nbsp;</li> <li>Ability for occasional business travel&nbsp;</li> </ul> <p><strong>Preferred</strong></p> <ul> <li>Advanced degree preferred.</li> </ul> <p>&nbsp;</p><div class="content-pay-transparency"><div class="pay-input"><div class="title">Wisconsin pay range </div><div class="pay-range"><span>$280,000</span><span class="divider">&mdash;</span><span>$340,000 USD</span></div></div></div><div class="content-conclusion"><p>Arrowhead provides competitive salaries and an excellent benefit package.&nbsp;&nbsp;&nbsp;</p> <p>All applicants must have authorization to work in the US for a company.&nbsp;&nbsp;&nbsp;</p> <p><a href="https://arrowheadpharma.com/wp-content/uploads/2023/09/Arrowhead-California-Applicant-Privacy-Policy.pdf" target="_blank">California Applicant Privacy Policy</a></p></div>