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Technical Resources International, Inc.
PRINCIPAL, QA
Career Insights for Clinical Quality Manager
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Based on Maryland data
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What they do
A Clinical Quality Manager ensures that the quality of the work in a clinical environment is consistent and meets government and industry standards as well as customer expectations. Verifies compliance with health and safety regulations. Coordinates all activities related to quality assurance and monitoring and revises existing processes in order to increase efficiency.
$116,627 / year median in Maryland
Job Description
PRINCIPAL, QA
- 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 We are equal opportunity/affirmative action employers, committed to diversity in the workplace.