Vice President, Quality

Arrowhead Pharmaceuticals•Verona, WI

22h

About The Position

Arrowhead Pharmaceuticals, Inc. (Nasdaq: 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. 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 Position 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. 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. This position has oversight of both Quality Assurance groups as well as the Quality Control laboratory function within the organization.

Requirements

BS in Life Sciences or related discipline
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
10+ years in a previous management role
Experience with developing a QMS and hosting successful regulatory agency inspections
Ability to thrive in a fast-paced environment, with experience in sponsor quality oversight responsibilities for contract vendors across all GxP areas
Implementation of internal phase appropriate GMP drug substance manufacturing & testing systems
Prior successful management of a Quality Management System for commercial product
Drug development through commercial manufacturing compliance experience
Excellent oral and written communication skills required
Strong computer skills utilizing a Microsoft environment (e.g. Word, Excel, Access, PowerPoint)
Familiarity with electronic document managements systems, Part 11 compliance and electronic document archiving systems
Ability for occasional business travel

Nice To Haves

Advanced degree preferred.

Responsibilities

Develop and facilitate Quality Systems as delineated in the Quality Manual to support Arrowhead’s clinical development pipeline and preparations for product commercialization
Implement and maintain an overall Quality Management System (QMS) meeting the requirements of activities conducted within Arrowhead
Develop and oversee the internal Quality Control (QC) lab department and operations
Support activities relating to clinical QA GCP regulations at the Pasadena location
Ensure systems are in place for conducting and tracking employee training required by GxP regulations
Support efforts pertaining to internal design, construction, commissioning, and qualification of GMP facilities
Review and approve outsourced contract manufacturing documentation such as validation protocols and reports; master batch records; deviations; analytical methods and methods validation; executed batch documentation; labels; and packaging records
Maintain a system for qualification of GxP vendors and coordinate auditing of GxP vendors
Ensure an system for GXP vendor qualification
Establish Quality Agreements with GMP vendors
Lead development and maintenance of service and supplier vendor qualification programs
Perform investigations into non-conformances and product deviations
Document and determine CAPAs, change controls required for internal cGMP processes as well as oversight of these investigations and corrective actions with external vendors
Implement and maintain a validated document control system, and develop SOPs/Work Instructions (WI) across functional areas impacting GMP, GLP, and GCP
Lead communication and interaction with Qualified Person (QP) to support investigational and commercial product supply chain in Europe
Participate in hosting audits or inspections of Arrowhead’s QMS by regulatory agencies, development partners and licensees
Participate in the established review cycle of QA controlled documents and GxP procedures to assure practices reflect written procedures
Keep supervisor abreast of significant issues or developments identified during quality activities, as well as actions to be taken for continuous improvement of quality systems
Maintain a working knowledge of government and industry quality assurance codes and standards to ensure compliance to GxP regulations
Participate in the establishment and maintenance of an internal system for documentation organization and retention that meets global regulatory requirements and corporate business needs
Lead the annual management review of the overall Quality Management System and associated data
Hiring, development, and leadership of Quality department staff