Vice President, Quality

• 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

• 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

Advanced degree preferred

competitive salaries and an excellent benefit package