Director, Clinical Quality Assurance

Role: Director of Clinical Quality Assurance (CQA) overseeing GCP compliance for clinical research in a biopharma setting. Responsibilities: lead global quality strategy implementation, manage CQA programs, oversee CRO/vendor compliance, support inspection readiness, and drive continuous improvement across clinical trials. Collaborates with internal teams and external stakeholders to ensure adherence to ICH GCP, FDA, EMA, and other regulations, promoting a quality and compliance culture. Requirements: 14+ years in pharmaceutical or biotech industries with deep GCP knowledge, audit expertise, risk management skills, and strong leadership. Qualifications: Bachelor's in science or related field; advanced degrees preferred. High-value details: Focus on oncology and neuroscience therapeutics, supporting clinical development stages from IND to Phase 3, with compliance and inspection management responsibilities. Skills: proficiency with eQMS, eTMF, excellent communication, organizational, and problem-solving abilities. Attributes: trusted leader with strong interpersonal skills, committed to continuous learning and operational excellence. Location: not specified, likely hybrid or on-site based on the nature of responsibilities.