Senior Manager, Clinical Quality Assurance

Role: Lead GCP quality activities in clinical development programs, ensuring compliance and inspection readiness. Responsibilities: develop and manage the Quality Strategy plan, conduct audits, interpret regulations, and serve as the primary quality liaison during health authority inspections. Collaborate with R&D and development operations to mitigate risks and drive proactive quality management across multiple clinical projects. Requirements: Bachelor's in a physical or life sciences, nursing, pharmacy, or related field; 5+ years in GCP QA, regulatory affairs, or clinical development; at least 1 year of GCP auditing experience. Preferred: experience in oncology or pharmaceutical industry leadership, strategic planning, and cross-functional execution. HighValue: focus on global GCP compliance, clinical development oversight, audit program design, and health authority interactions. WorkSetup: Not specified.