Senior Manager, GCP Audit and Inspection Management
: Non-Executive Management
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Job Description: : The Sr. Manager, GCP Audit and Inspection Management Quality Assurance is responsible for the oversight and execution of quality audit activities related to clinical trial execution, including audits of GCP CRO compliance, contributing to and executing audit plans, supporting inspection readiness activities, etc. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone who is not afraid to dive in and help this expanding team. Position may require up to 30% national/international travel. Key Responsibilities: * Develops, maintains, and executes Audit Plans, supporting Clinical Studies/Programs * Conducts Clinical Vendor, Clinical Investigator and Clinical Document Audits * Provides oversight for audits that are outsourced * Executes directed or For-Cause GCP audits, as needed * Engages in Preparation, Support and Follow-up activities for Inspection Readiness * Provides regulatory compliance support & guidance to cross functional clinical study teams, as requested * May serve as GCP Quality Management System representative * Participates in collaborative review of impacted SOP/WI * Reviews and analyzes key Performance Indicator data and trends * Analyzes risk and proposes remedial, corrective and /or preventive actions * May participate on process improvement initiatives * Provides cross-functional support across the QA team #LI-SO1 Qualification: * M.S. (or equivalent degree) and 7+ years of relevant work experience, or * B.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background In-depth knowledge in the following areas: * Clinical Audit processes * GCP Quality Systems * Global GCP regulations (US/EU etc.); ICHE6 R2, 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary * Clinical Documentation (e.g., Investigator's Brochures, Clinical Study Reports, Protocols, etc.) * Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques * Risk management principles and process, change management * Phases 1-4 clinical trial within the drug development life cycle and regulatory requirements, best practices, industry standards