Quality Assurance Manager-Good Clinical Practice (GCP)

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.