Technical Resources International
Quality Assurance Manager-Good Clinical Practice (GCP)
Technical Resources International, Bethesda, Maryland, us, 20811
Job Title
Quality Assurance Manager-Good Clinical Practice (GCP)
Location
Bethesda, MD 20817 US (Primary)
Category
Quality Assurance
Job Type
Full-Time
Salary Range
$115,000-$130,000
Education
Bachelor's Degree
Travel
Up to 25%
Job Description
Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance. Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations. Reviews clinical audit reports and provides guidance to auditors. Supports inspection readiness program. Serves as a subject matter expert for quality. Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System. Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations. Supports regulatory authority inspection. Job Requirements
Experience working in Quality Assurance GCP internal and client audits (minimum 5 years). Experience working with eQMS. Proficiency in MS Office. Experience with supervising staff. Travel 25% (local, domestic, and international). Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
Quality Assurance Manager-Good Clinical Practice (GCP)
Location
Bethesda, MD 20817 US (Primary)
Category
Quality Assurance
Job Type
Full-Time
Salary Range
$115,000-$130,000
Education
Bachelor's Degree
Travel
Up to 25%
Job Description
Conducts clinical site audits (domestic and international) verifying regulatory compliance and protocol compliance. Verifies clinical compliance to applicable Standard Operating Procedures (SOPs) and regulations. Reviews clinical audit reports and provides guidance to auditors. Supports inspection readiness program. Serves as a subject matter expert for quality. Promotes quality by reviewing work instructions, providing training to staff, and supporting the Quality Management System. Hosts client audits, conducts external audits at clinical sites and vendor sites, leads process improvement activities and CAPA investigations. Supports regulatory authority inspection. Job Requirements
Experience working in Quality Assurance GCP internal and client audits (minimum 5 years). Experience working with eQMS. Proficiency in MS Office. Experience with supervising staff. Travel 25% (local, domestic, and international). Minimum a B.S/B.A., Certified Quality Auditor (CQA) preferred, advanced degree preferred.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.