Current openings at Arrowhead Pharmaceuticals

The Position The purpose of this position within the Quality and Compliance department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) align with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff, business operations per strategic business needs. Responsibilities Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management. Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules oligo- and polynucleotides and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects. Provide leadership in product testing and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance. Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas. Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ). Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner’s needs. Represent QC function during 3rd party, QP, and regulatory inspections at Verona, WI facility. Hiring and development of QC department staff at the Verona, WI Other duties consistent with the position as assigned from time to time. Requirements: Master's Degree  10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research 5 years of experience Directing QC laboratory in cGMP facility. Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable compliance programs. Knowledge of GLP/GCP regulations Understanding of document control requirements in a FDA regulated Competent knowledge of and ability to use Microsoft Word and Excel Ability for occasional business Strong people leadership skills. Solid understanding of financials and budgetary management experience. Knowledge and understanding of operation of product quality control lab, product quality control requirement and system. Shows broad understanding of the issues relevant to the technical/science and business Preferred:  Doctorate degree   

The Position The primary purpose of the position is to oversee the eTMF process and vendor, ensure compliance with GCP and consistency across the programs, and to provide guidance and best practices to Clinical Operations.  In addition, the Associate Director of Clinical Standards & Processes will be tasked with tracking and ongoing Standard Operating Procedure/ Work Instruction (SOP/WI) review and updates as well as aligning with Quality Assurance (QA) to ensure Good Clinical Practice (GCP). Responsibilities Provide leadership, guidance and oversight on study related issues pertaining to the eTMF, unblinded tasks, and company processes. eTMF system administrator and trainer for all internal and external Direct Clinical Operations staff with eTMF set-up, maintenance, ongoing quality control review, and final reconciliation of study Ensure staff is provided GCP/SOP/WI training for Clinical Operations staff and refreshers where applicable. Ensure the collection of metrics and tracking systems to facilitate a proactive, risk-based quality management Oversee clinical vendor management and escalate issues as required to Senior Collaborate with Quality Assurance on health authority inspection preparation activities and provide leadership and oversight during Collaborate with Quality Assurance with the preparation, conduct and response to internal and external audits/inspections, as applicable. Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to COM and Senior Management, as Contribute to the development of Clinical Operations documents (forms, templates, SOPs/Wls). Ensure consistency and standardization of processes across Clinical Operations. Collaborate with other cross functional areas (Safety, Regulatory, Legal, Finance, Project Management and QA) to ensure operational Manage direct reports. Requirements: 10 years of relevant experience in clinical operations/clinical quality or quality assurance role/ minimum of 3 years in a managerial or lead role/ minimum of 2 years in clinical monitoring experience (preferred). 3 years Veeva eTMF experience in a management role. Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) Experience in inspection Strong knowledge/experience in vendor management, clinical operations and management of electronic Trial Master Files (Veeva eTMF). Preferred:  Master's degree in a Science discipline Knowledge of industry compliance trends