Clinical Research professional - GCP Quality Auditor

Summary

Clinical Quality Assurance professional with 7+ years of GCP auditing, clinical documents review, managing quality
management and supporting regulatory inspection readiness across Pharma, Biotech and CRO environments. Led GCP
investigator site, vendor and system audits across Phase IIII global clinical trials in alignment with ICH E6(R2)/E6(R3), ICH
E8(R1), 21 CFR Parts 11, 50, 54, 56 and 312. Subject matter expert in conducting risk-based quality management (RBQM)
different clinical audits, clinical data and documents review, SOP review, Deviation - Root cause analysis - CAPA
management and TMF/e-TMF quality oversight to ensure patient safety, data integrity and regulatory compliance.
Supporting FDA inspection readiness and driving measurable reductions in repeat audit findings through continuous quality
process improvement.
Collaborates effectively with cross-functional teams including Clinical Operations, Data
Management, Regulatory Affairs and Pharmacovigilance with demonstrated ability to mentor junior QA professionals and
contribute to a strong clinical quality culture.
Permanent Resident, authorized to work in the U.S.

Expectations

Looking for opportunity in Pharmaceutical / Biotechnology and Research Organizations as a Clinical Research Professional.

Employment Preferences

Expected Base Salary

**,000 USD

Academic Degree

Experience

Skills

• REGULATORY FRAMEWORKS
• GUIDELINES
• ICH E6
• R2
• E6
• R3
• ICH E8
• R1
• 21 CFR Parts 11
• GDPR · ALCOA+ Data Integrity · FDA · EMA · MHRA
• CLINICAL QUALITY ASSURANCE
• Risk-Based GCP Auditing
• Site
• Vendor
• CRO
• System
• Internal
• Audit Program
• Management · Quality Management System
• QMS
• CAPA Management · Root Cause Analysis · Deviation Management
• INSPECTION READINESS
• FDA Inspection Support · Pre-Inspection Gap Assessments · Sponsor Inspection Support
• DOCUMENTATION
• QUALITY GOVERNANCE
• SOP Development
• Lifecycle Management · Trial Master File
• TMF
• ETMF
• Quality Oversight · TMF Reference Model · Essential Documents
• Quality Plans · Audit Reports
• CAPA
• Tracking
• VENDOR
• SPONSOR OVERSIGHT
• Vendor Qualification Audits · CRO Governance · Sponsor Oversight · Clinical Quality
• Agreements
• CQAs
• Functional Service Provider
• FSP
• Model · Issue Escalation
• CROSS-FUNCTIONAL COLLABORATION
• Clinical Operations · Data Management · Regulatory Affairs ·
• Pharmacovigilance · Medical Affairs · Mentoring
• Training
• SYSTEMS
• TOOLS
• Veeva Vault
• Medidata Rave
• EDC
• CTMS · SharePoint · Microsoft Office Suite
• Excel
• Word
• PowerPoint
• Outlook
• Teams