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Job Description
HYBRID, 2 DAYS PER WEEK IN BETHESDA MD. MUST BE LOCAL TO MONTGOMERY COUNTY, MD.
Job details
Posted
27 May 2025
Location
Bethesda, MD
Job type
Permanent
Reference
Job Description
HYBRID, 2 DAYS PER WEEK IN BETHESDA MD. MUST BE LOCAL TO MONTGOMERY COUNTY, MD.
GCP Quality Assurance Manager
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.
- 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., advanced degree preferred.
- Certified Quality Auditor (CQA) preferred.
Dexians brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit to learn more.
Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.
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IT Services and IT Consulting
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