PRINCIPAL, QA

Technical Resources International, Inc.; Bethesda (MD); On-site; USD 95,000 - 130,000; Full time

Job summary

Technical Resources International, Inc. seeks a Quality & GCP Compliance professional to oversee regulatory adherence and audits across clinical sites and CRO vendors, ensuring all activities meet SOPs and applicable regulations.

The role leads CAPA investigations, supports the Quality Management System, trains junior staff, guides regulatory inspections, and contributes to process improvements, with a focus on clear written and verbal communication.

Qualifications

• 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 and verbal communication skills.

Responsibilities

• Verifies GCP compliance to SOPs and regulations at sites.
• Conducts audits of clinical sites and vendors/suppliers.
• Provides full support to the Quality Management System.
• Conducts 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 sites.
• Trains junior staff on regulations and quality processes.
• Supports regulatory authority inspections.
• Supports business development activities, as requested.

Skills

GCP regulatory knowledge

Regulatory inspections experience

Quality Systems for CROs

GCP site audits

Written and verbal communication

Tools

MS Office

Job description

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