Senior GLP Quality Assurance Specialist
The Position
The purpose of this position within the Quality Assurance department is to support ongoing development programs for preclinical and clinical drug candidates at Arrowhead. A key function of the position will involve the continued development and maintenance of quality systems supporting Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) within the organization. The candidate will be expected to interact with multiple internal departments, as well as assist with quality oversight functions for external organizations.
Responsibilities:
- Contribute to the development of a GLP quality and compliance systems to support non-clinical and clinical phase drug development
- Writing, review, change control, approval, issuance, and organization of Standard Operating Procedures (SOPs)
- Organization and control of quality, compliance, and project related documentation
- Support utilization of an electronic document management system (Veeva QualityDocs)
- Review and approval of internal and vendor generated documentation
- Perform Quality related tasks in coordination with Bioanalytical and DMPK
- Issuance, review, tracking, and completion of internal deviations, out of specifications, and CAPAs
- Auditing of vendor and internal documentation and files
- Assisting with generation, tracking, monitoring, and reporting of key quality metrics
- Maintain knowledge of current compliance expectations and regulations pertaining to GLP/GCP testing
- Collaborate with, and provide quality support for, other departments (Bioanalytical, DMPK, Project Management, Toxicology, Clinical Operations, etc.)
- Participate in meetings with vendors and external organizations as the QA team representative
- Other duties consistent with the position as assigned from time to time
Requirements:
- Bachelor’s degree in a science field
- Minimum of 8 years of experience in a pharmaceutical development company and/or contract research organization
- Working knowledge of drug GLP regulations, as well as ICH/FDA guidance documents
- Previous experience with GLP/GCP quality systems, specifically 21 CFR Part 58
- Prior experience with use of an electronic document management system in a regulated environment
- Understanding of document control requirements in a FDA regulated organization
- Competent knowledge of and ability to use Microsoft Word and Excel
- Ability for occasional business travel
- Excellent written and verbal communication skills and ability to communicate 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 with minimal supervision and as well as manage priorities within a fast-paced environment
- A detail-oriented self-starter who endeavors to anticipate and resolve problems and seeks opportunities to grow their role and responsibilities at Arrowhead