INACTIVE
Full-Time
Manager – Clinical Quality Assurance Auditor
Posted on 4/16/2024
Develops RNAi-based therapies for diseases
Biotechnology
Compensation Overview
$120,000 - $145,000Annually
+ Competitive salaries + Excellent benefit package
Mid, Senior
Remote in USA
Required Skills
Google Cloud Platform
Requirements
- Minimum of 5 years of relevant experience in GxP auditing and compliance
- Strong knowledge of GCP/GCLP/GVP and Food & Drug Administration (FDA), European regulations and ICH guidelines
- Prior GCP/GCLP/GVP auditing, training, and or compliance investigation experience is required.
- Minimum of a bachelor's degree in a Science discipline is required
- Requires approximately >50% travel
Responsibilities
- Independently conduct Clinical Investigator Site Audits, Vendor, Internal System Audits, GCP/GxP Document Audits (Clinical Study Reports and Trial Master Files)
- Manage a vendor/site audit tracking system, and assist with planning and scheduling future requalification requirements
- Author and manage Audit Plans and Audit Reports
- Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
- Support health authority inspections
- Communicate any serious or critical compliance risks noted from these activities to senior management (manage report of Serious Breaches)
- Participates and leads in generating, training, evaluating, and executing, as required, Arrowhead Standard Operating Procedures and Work Instructions regarding GCP/GCLP/GxP, industry guidelines (such as International Council of Harmonization-ICH) and global regulations
- Issuance, review, tracking, and completion of deviations and CAPAs
- Keep up to date with all related quality legislation and compliance issues. Ensure regulations are communicated through development of corporate policies and procedures
- Work with Clinical Development on identifying and mitigating any compliance issues
- Direct contract auditors and others who oversee activities performed by contract auditors
- Ensure vendor/site audit and qualification documentation is properly maintained in Veeva electronic repositories
Arrowhead Pharmaceuticals specializes in developing RNAi-based therapies using their TRiM platform, which leverages various RNA chemistries for tissue-specific targeting, enabling rapid and durable knockdown of disease-causing genes. The TRiM platform also utilizes ligand-mediated delivery, offering potential advantages such as simplified manufacturing, reduced costs, and improved safety.
Company Stage
IPO
Total Funding
$899.9M
Headquarters
Pasadena, California
Founded
2004
Growth & Insights
Headcount
6 month growth
↑ 9%1 year growth
↑ 27%2 year growth
↑ 61%INACTIVE