Principal QA - GCP Audits & CAPA Lead (Remote)

Technical Resources International, Inc.; Bethesda (MD); Remote; USD 120,000 - 145,000; Full time

Job summary

Technical Resources International, Inc. is seeking a Principal, QA to lead quality oversight for GCP-compliant clinical trials in the Bethesda area.

You will conduct site and vendor audits, support the Quality Management System, and drive CAPA investigations to ensure regulatory readiness. Applicants should have strong knowledge of current GCP regulations, experience with regulatory inspections, and proficiency with MS Office.

Qualifications

• Requires strong knowledge of current GCP regulations.
• Experience with regulatory authority inspections.
• Experience working with Quality Systems for CROs.
• Experience conducting GCP clinical site audits.
• Proficiency in MS Office.

Responsibilities

• Verifies GCP compliance to SOPs and regulations.
• Conducts audits of clinical sites and vendors/suppliers.
• Supports 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.
• Trains junior staff on regulations and quality processes.
• Supports regulatory authority inspections.
• Supports business development activities as requested.

Skills

GCP regulations knowledge

Regulatory inspections experience

Quality Systems for CROs

GCP site audits

MS Office proficiency

Education

Bachelor's Degree

Tools

MS Office

Job description

Technical Resources International, Inc. is seeking a Principal, QA to lead quality oversight for GCP-compliant clinical trials in the Bethesda area.

You will conduct site and vendor audits, support the Quality Management System, and drive CAPA investigations to ensure regulatory readiness. Applicants should have strong knowledge of current GCP regulations, experience with regulatory inspections, and proficiency with MS Office.