Senior Manager, Clinical Program Quality and Excellence (Oncology)

Role: Senior GCP Quality Assurance Lead overseeing global clinical research programs across multiple units, including R&D, Plasma Derived Therapy, Vaccines, Oncology, and Medical Marketed Products Development. Objectives: ensure inspection readiness, provide strategic quality oversight, and lead preparation and management of GCP inspections, including pre-approval inspections. Responsibilities: develop risk-based audit and compliance strategies, conduct audits of sites, documents, vendors, and systems; investigate and facilitate resolution of quality issues; manage inspection responses; and report metrics to leadership. Requirements: BS/BA (advanced degree preferred), minimum 7 years in pharma/biotech, with at least 5 years in GCP QA or clinical trials; extensive knowledge of ICH GCP R2 and global regulations; proven audit expertise and risk mitigation skills; strong communication, project management, and analytical capabilities. Preferred: GCP QA certification. High-Value: GCP compliance, audit leadership, inspection management, clinical trial oversight, cross-functional collaboration, and experience with international audits. Work Setup: US-based remote position with approximately 30% travel, including international.