Senior Director, Clinical Quality Assurance (CQA)

For our client, we are seeking a Senior Director, Clinical Quality Assurance (CQA) to join the team of a leader in the Pharmaceuticals & Biotech space. This leader will oversee clinical quality strategy across multiple global studies, ensuring rigorous GCP compliance and operational excellence throughout the clinical development lifecycle. The role partners closely with Clinical, Quality, and Regulatory Affairs teams to strengthen study quality, manage risk, and support inspection readiness. This is a senior leadership position with the opportunity to guide quality systems, mentor team members, and influence the success of a fast-moving clinical organization. Location: Remote - US based candidates only, no visa sponsorship available Compensation: $245,000 – $286,000 annually Responsibilities Provide strategic quality leadership for multiple clinical studies Develop and implement clinical study quality plans, ensuring GCP compliance Manage and mentor Clinical QA staff and consultants Conduct risk-based GCP compliance audits of vendors and sites Oversee communication of audit findings and ensure timely escalation of issues Review and provide strategic input on clinical documents for quality and accuracy Qualifications Bachelor's degree in life science, nursing, pharmacy, or a related field; advanced degree preferred 12+ years of experience in a regulated environment such as Regulatory, Quality, Pharmacovigilance, or Clinical Development Proven leadership in clinical quality strategy and oversight of global clinical trials Minimum of 7 years in clinical quality assurance, specifically with GCP audits and global trials Experience with health authority inspections, including readiness preparation and follow-up Benefits Opportunity to lead and influence clinical quality strategy at a senior level Work in a fast-paced small company environment with a focus on collaboration Engagement with cross-functional teams including Clinical, Quality, and Regulatory Affairs Access to professional development and career advancement opportunities Our client is an equal opportunity employer. We encourage you to apply even if you don’t meet every qualification—your background could be exactly what this team needs.