Overview
Quality Assurance Auditor (Good Clinical Practice – GCP) Jobs in Rockville, MD at Dexian
Title: Quality Assurance Auditor (Good Clinical Practice – GCP)
Company: Dexian
Location: Rockville, MD
Remote (DC, MD, VA or NC Area Preferred)
Travel: Up to 25% domestic travel (within the DMV area) and 2-3 international trips annually
Position Summary
The Quality Assurance Auditor GCP supports the Quality Management System (QMS) to ensure compliance with ICH-GCP guidelines, FDA regulations, and global clinical research requirements. This role provides quality oversight of clinical trial activities, supports audit and inspection readiness, manages quality systems, and partners with internal teams, CROs, investigators, and vendors to drive compliance and continuous improvement.
Key Responsibilities
- Maintain and improve the Quality Management System (QMS), including document control, training, CAPA, deviations, and change control processes.
- Support GCP compliance across clinical trials, investigator sites, CROs, laboratories, and vendors.
- Conduct and support internal audits, vendor audits, and clinical site audits.
- Manage CAPAs, including root cause analysis, corrective actions, effectiveness checks, and closure.
- Lead document review cycles and ensure SOPs and quality documents remain current and compliant.
- Support regulatory inspections and inspection readiness activities, including FDA and international health authority audits.
- Track quality metrics, identify compliance trends, and recommend process improvements.
- Support vendor qualification, performance monitoring, and ongoing quality oversight.
Required Qualifications
- Bachelor’s degree in Life Sciences or related field.
- 3+ years of Quality Assurance auditing experience
- Strong knowledge of ICH-GCP, FDA regulations, and clinical trial processes.
- Experience supporting regulatory inspections, GCP audits, and quality systems.
- Working knowledge of CAPA, document control, training management, and vendor oversight.
- Excellent communication, organizational, and problem-solving skills.
- Proficiency in Microsoft Office Suite.
Preferred Qualifications
- Experience working within a CRO, pharmaceutical, biotechnology, or medical device environment.
- Experience with electronic QMS systems (Veeva, MasterControl, TrackWise, etc.).
- ASQ certification or other quality-related certifications.
- Experience supporting global clinical trials and regulatory inspections.
Dexian stands at the forefront of Talent + Technology solutions with a presence spanning more than 70 locations worldwide and a team exceeding 10,000 professionals. As one of the largest technology and professional staffing companies and one of the largest minority-owned staffing companies in the United States, Dexian combines over 30 years of industry expertise with cutting-edge technologies to deliver comprehensive global services and support.  
 
Dexian connects the right talent and the right technology with the right organizations to deliver trajectory-changing results that help everyone achieve their ambitions and goals. To learn more, please visit https://dexian.com/.
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.
