Assoc Dir Clinical QA - Remote

About the position Responsibilities • Provides Quality oversight and support of Tolmar Inc. clinical development programs. • Supports the Tolmar Inc. Clinical Quality Management System through the development, implementation and management of Quality Assurance procedures, processes and systems in accordance with ICH E6 (Rx). • Executes on and/or provides oversight of quality monitoring and assurance of clinical trial execution of Tolmar Inc. sponsored protocols. • Executes on and/or provides oversight of clinical investigator audits, documentation audits and other study-specific or process audits. • Engages with study teams and functions for proactive inspection readiness across all clinical programs. • Conducts external and internal audits to assess compliance with GCP requirements, investigational plans and company standards for clinical trial-related activities. • Communicates audit findings to audit stakeholders ensuring understanding as well as collaborating with auditees to develop Corrective and Preventive Action Plans (CAPAs), addressing root causes. • Tracks, reviews, approves, and assesses the efficiency of CAPAs. Requirements • Experience in clinical quality assurance and compliance with GCP principles. • Knowledge of FDA, EMA, Health Canada, and ICH regulations. • Strong analytical and problem-solving skills. • Excellent communication and collaboration skills. Nice-to-haves • Experience with clinical trial management systems (CTMS). • Familiarity with electronic data capture (EDC) systems. Benefits • Health insurance coverage. • 401k retirement savings plan. • Paid holidays and vacation days. Apply tot his job Apply To this Job