GCP Quality Assurance Manager

Dexian; Bethesda (MD); Hybrid; USD 85,000 - 110,000; Full time

Job summary

A leading company in staffing seeks a GCP Quality Assurance Manager for a hybrid role based in Bethesda, MD. The manager will handle clinical site audits, ensure regulatory compliance, and enhance quality management systems. Ideal candidates will have substantial experience in quality assurance, a background in clinical audits, and a relevant degree. Join a dedicated team committed to ensuring the highest quality standards in clinical research.

Qualifications

• Minimum 5 years experience in Quality Assurance GCP internal and client audits.
• Experience supervising staff.
• Proficient in eQMS and MS Office.

Responsibilities

• Conducts domestic and international clinical site audits.
• Verifies regulatory compliance and provides guidance to auditors.
• Supports inspection readiness and leads CAPA investigations.

Skills

Quality Assurance

Clinical Compliance

Regulatory Compliance

Training

Process Improvement

Education

B.S/B.A

Advanced degree

Certified Quality Auditor (CQA)

Tools

eQMS

MS Office

Job description

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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.

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., advanced degree preferred.
• Certified Quality Auditor (CQA) preferred.
  

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals.

Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Other

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