Associate Director, Clinical Quality Assurance

Role: Associate Director, Clinical Quality Assurance at Vera Therapeutics, serving as a key partner to clinical study teams to ensure high-quality, compliant clinical development activities. Responsibilities: provide proactive oversight of clinical quality events, investigations, and CAPAs; analyze quality signals across studies and vendors to identify risks; support audit program governance, inspection readiness, and quality process improvements; serve as a quality interface with CROs and vendors; review SOPs and training matrices to ensure compliance. Requirements: Bachelor's in life sciences, pharmacy, or related field; 8+ years of industry experience in clinical quality oversight or governance; strong knowledge of global GxP regulations including GCP, GVP, and GLP; experience in clinical trial quality management, CAPA, inspection support, risk-based quality approaches, and audit planning; certifications such as RQAP, CQA, CCRC, or RAC preferred. High-Value: focus on clinical development in autoimmune diseases, with emphasis on GCP compliance, inspection readiness, and quality oversight across clinical trials. Collaboration: cross-functional interaction with Clinical Ops, Pharmacovigilance, Data Management, and Regulatory teams. Work Setup: not specified, but implies a role integrated within clinical development functions.