Arrowhead Pharmaceuticals is looking to solve the problem of developing innovative drugs for diseases with a genetic basis by hiring a Team Leader in the Quality Assurance department to support on-going development programs for preclinical, clinical, and commercial drug candidates.
Requirements
- Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
- Understanding of document control requirements in an FDA regulated organization.
- 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 use of an electronic document management system in a regulated environment.
- Knowledge of current compliance expectations and regulations pertaining to drug development.
- Experience working in a regulated environment with preference to quality assurance auditing and/or manufacturing experience.
Responsibilities
- Participate in meetings as the QA team representative as needed.
- Collaborate with, and provide quality support for, other departments (Manufacturing, QC, Project Management, Analytical Development, etc.)
- Writing, review, change control, approval, issuance and organization of procedural documents, and controlled documents.
- Support utilization of an electronic document management system (Veeva Quality) for, but not limited to, 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 (QE) as needed.
Other
- Bachelor's degree in a science discipline, or equivalent required.
- 6 years of experience working in a regulated environment with preference to quality assurance auditing and/or manufacturing experience.
- Excellent written and verbal communication skills and 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.
- Ability for occupational business travel.
