Job Title
PRINCIPAL, QA
Location
Bethesda, MD 20817 US (Primary)
Category
Quality Assurance
Job Type
Full-Time
Salary Range
$120,000-$145,000
Education
Bachelor's Degree
Travel
Up to 25%
Job Description
- Verifies GCP compliance to applicable Standard Operating Procedures (SOPs) and regulations
- Conducts audits of clinical sites and vendors/suppliers
- Provides full support to the Quality Management System
- Conduct external audits at clinical sites and vendor sites
- Leads process improvement activities and CAPA investigations
- Reviews clinical quality management plans and provides consultative support to clinical sites (as applicable.
- Trains junior staff on regulations and quality processes
- Supports regulatory authority inspections
- Supports business development activities, as requested
Job Requirements
- Strong knowledge of current GCP regulations
- Experience with regulatory authority inspections
- Experience working with Quality Systems for CROs
- Experience conducting GCP clinical site audits
- Excellent written/verbal communication skills
- Proficiency in MS Office
- This role is fully remote for those living in the DMV area.
