Associate Director, Clinical Quality Assurance

Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics’ flagship commercial product is TRUTAKNATM (atacicept-vymj), a B-cell activating factor (BAFF) and A proliferation-inducing ligand ( APRIL) inhibitor. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit www.veratx.com . At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner’s mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney. Position Summary: The Associate Director, Clinical Quality Assurance, will report to the Executive Director, Quality Assurance. The Associate Director, Clinical Quality Assurance serves as a key quality partner to clinical study teams and provides quality oversight of clinical development activities. This role contributes to strengthening a maturing Quality Management System (QMS) by identifying quality risks, supporting risk-based decision making, and ensuring quality practices are effectively implemented across clinical programs. The Clinical Quality Assurance organization partners with Clinical Development and cross-functional stakeholders to promote and maintain high-quality clinical research practices across the drug development lifecycle. The function provides quality oversight to ensure clinical trials are conducted in compliance with global regulatory requirements and that the organization maintains continuous inspection readiness. This role provides proactive Clinical Quality Assurance oversight for clinical studies and development functions. The individual partners closely with Clinical Operations, Pharmacovigilance, Data Management, Regulatory Affairs, and other development function and serves as a key member of study teams, helping identify quality issues and risks, and reviews quality events, investigations, and CAPAs; analyzing quality signals across studies and vendors that support risk-based decision making, and ensuring quality management practices are appropriately implemented throughout the clinical trial lifecycle. The role operates with a high degree of independence in evaluating quality risks and compliance considerations while collaborating closely with cross-functional teams to support effective implementation of quality practices across clinical development programs. The position contributes to strengthening the organization’s maturing Quality Management System (QMS) by supporting procedural governance, audit program oversight, and quality process improvement initiatives. Responsibilities: Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations. Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends. Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies. Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function. Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues. Support inspection readiness activities and provide…