Arrowhead Pharmaceuticals, Inc.
Team Lead, Quality Assurance
Arrowhead Pharmaceuticals, Inc., Verona, Wisconsin, United States, 53593
The Position
The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Key functions include people management and QA review of complex internally generated manufacturing data and associated documents within QA, and supporting general quality systems related to current Good Manufacturing Practices (cGMP). The Team Leader is expected to interact with multiple internal departments. Responsibilities
Participate in meetings as the QA team representative as needed. Manage and mentor direct reports. Collaborate with, and provide quality support for, other departments (Manufacturing, QC, Project Management, Analytical Development, etc.). Write, review, change control, approve, issue, and organize procedural documents and controlled documents. Support utilization of an electronic document management system (Veeva Quality) for electronic batch disposition and release, quality events, and updating of procedural documents. Independently review and approve internally and externally generated documentation including, but not limited to, validations, stability/release data, manufacturing data, and associated reports, certificates of analysis, and batch records. Perform evaluation of facilities for compliance and cleanliness through room release and QA on-the-floor activities as needed. Independently assess and approve investigations, deviations, and other quality events as needed. Organize and control project-related documentation. Maintain knowledge of current compliance expectations and regulations pertaining to drug development. Assist with Good Documentation Practices, Good Manufacturing Practices (GMP), and data integrity training as needed. Support manager with day-to-day activities. Additional duties as assigned. Requirements
Bachelors degree in a science discipline, or equivalent required. 6 years of experience in a regulated environment, with preference to quality assurance auditing and/or manufacturing experience. Excellent written and verbal communication skills; ability to communicate effectively with internal and external parties. Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best-in-class quality assurance protocols. Highly motivated team player willing to contribute to a growing pharmaceutical organization. Ability to work independently and manage priorities within a fast-paced environment. Detail-oriented self-starter who anticipates and resolves problems and seeks opportunities to grow responsibilities at Arrowhead. Working knowledge of drug GMP regulations and ICH/FDA guidance documents. Understanding of document control requirements in an FDA-regulated organization. Ability for occupational business travel. Preferred
Additional quality-related certifications. Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15). Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet. Prior experience with an electronic document management system in a regulated environment. Wisconsin pay range: $80,000$100,000 USD. Arrowhead provides competitive salaries and an excellent benefits package. All applicants must have authorization to work in the US for a company. #J-18808-Ljbffr
The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical, clinical, and commercial drug candidates at Arrowhead. Key functions include people management and QA review of complex internally generated manufacturing data and associated documents within QA, and supporting general quality systems related to current Good Manufacturing Practices (cGMP). The Team Leader is expected to interact with multiple internal departments. Responsibilities
Participate in meetings as the QA team representative as needed. Manage and mentor direct reports. Collaborate with, and provide quality support for, other departments (Manufacturing, QC, Project Management, Analytical Development, etc.). Write, review, change control, approve, issue, and organize procedural documents and controlled documents. Support utilization of an electronic document management system (Veeva Quality) for electronic batch disposition and release, quality events, and updating of procedural documents. Independently review and approve internally and externally generated documentation including, but not limited to, validations, stability/release data, manufacturing data, and associated reports, certificates of analysis, and batch records. Perform evaluation of facilities for compliance and cleanliness through room release and QA on-the-floor activities as needed. Independently assess and approve investigations, deviations, and other quality events as needed. Organize and control project-related documentation. Maintain knowledge of current compliance expectations and regulations pertaining to drug development. Assist with Good Documentation Practices, Good Manufacturing Practices (GMP), and data integrity training as needed. Support manager with day-to-day activities. Additional duties as assigned. Requirements
Bachelors degree in a science discipline, or equivalent required. 6 years of experience in a regulated environment, with preference to quality assurance auditing and/or manufacturing experience. Excellent written and verbal communication skills; ability to communicate effectively with internal and external parties. Ability to work with diverse professionals and promote cooperation, shared understanding, and commitment to ensuring best-in-class quality assurance protocols. Highly motivated team player willing to contribute to a growing pharmaceutical organization. Ability to work independently and manage priorities within a fast-paced environment. Detail-oriented self-starter who anticipates and resolves problems and seeks opportunities to grow responsibilities at Arrowhead. Working knowledge of drug GMP regulations and ICH/FDA guidance documents. Understanding of document control requirements in an FDA-regulated organization. Ability for occupational business travel. Preferred
Additional quality-related certifications. Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15). Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet. Prior experience with an electronic document management system in a regulated environment. Wisconsin pay range: $80,000$100,000 USD. Arrowhead provides competitive salaries and an excellent benefits package. All applicants must have authorization to work in the US for a company. #J-18808-Ljbffr