Quality Assurance Manager-Good Clinical Practice (GCP)

Technical Resources International, Inc.; Bethesda (MD); On-site; USD 115,000 - 130,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Manager to oversee Good Clinical Practice (GCP) audits and ensure compliance with regulatory standards. In this pivotal role, you will conduct both domestic and international audits, support inspection readiness, and promote quality through training and process improvements. Your expertise will guide the quality management system and ensure the highest standards are met. This position offers a dynamic environment where your contributions will directly impact the success of clinical operations. If you are passionate about quality assurance and ready to take the next step in your career, this is the opportunity for you.

Qualifications

• 5+ years of experience in Quality Assurance GCP audits.
• Proficiency in eQMS and MS Office required.

Responsibilities

• Conduct clinical site audits ensuring regulatory compliance.
• Support inspection readiness and lead process improvement activities.

Skills

Quality Assurance

GCP Audits

Regulatory Compliance

Process Improvement

Training

Supervising Staff

Education

Bachelor's Degree

Certified Quality Auditor (CQA)

Advanced Degree

Tools

eQMS

MS Office

Job description

Quality Assurance Manager-Good Clinical Practice (GCP) - (QAMGR001_COMPANY_1.2)

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.