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Dexian · 1 day ago

Lead GCP Quality Assurance Auditor

Bethesda, MD

Full-time

Hybrid

Senior Level

Dexian is a leading technology and professional staffing company with a global presence. They are seeking a Lead GCP Quality Assurance Auditor to support the maintenance of the Quality Management System and manage various QA programs, including audits and document control.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Responsibilities

Supports the maintenance and upkeep of the Quality Management System

Maintains the Quality Assurance (QA) training program, document control, customer complaint program and CAPA program

Supports audits of clinical sites and vendors/suppliers

Supports internal audit program and performance metrics system for continual improvement

Manages the review cycle of QA controlled documents to assure practices reflect written procedures

Supports regulatory agency audits

Qualification

GCP regulationsRegulatory agency auditsQuality Systems for CROsQA training programMS OfficeWritten/verbal communication

Required

Knowledge of current GCP regulations

Experience in working with regulatory agency audits

Experience in working with Quality Systems for CROs

Excellent written/verbal communication skills

Proficiency in MS Office

Company

Dexian

Glassdoor3.5

Dexian provides services for staffing, talent development, and consulting, with a focus on technology, finance, and project management.

Founded in 1994

Mclean, Virginia, USA

1001-5000 employees

https://dexian.com

H1B Sponsorship

Dexian has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (65)