Senior Manager, Clinical Quality Assurance

Role: Lead GCP quality management for clinical studies across one or more programs, ensuring compliance and inspection readiness. Responsibilities: develop and oversee the implementation of the comprehensive quality strategy, including risk and issue management, audit programs, and quality assessments; interpret and apply regulatory requirements; collaborate with development operations to maintain quality standards; serve as a key quality liaison during inspections; identify and mitigate clinical quality risks; and influence proactive quality practices across R&D. Requirements: Bachelor's in a physical or life science, nursing, pharmacy, or equivalent; 5+ years in GCP quality assurance, regulatory affairs, or clinical development, with at least 1 year of GCP audit experience; demonstrated leadership and strategic planning skills; strong understanding of global pharma and clinical development environments. HighValue: global clinical development, GCP quality assurance, regulatory compliance, audit management, cross-functional leadership, oncology or immunology therapeutic areas preferred. Location: North Chicago, IL; Irvine, CA; South San Francisco, CA; Worcester, MA; Dublin, Ireland; Maidenhead, UK.