Senior Manager, Clinical Program Quality and Excellence (Oncology)

Role: GCP Quality Assurance Lead overseeing global clinical research programs at Takeda, focusing on inspection readiness and compliance across multiple therapeutic areas, including Oncology, Vaccines, Plasma Derived Therapies, and Medical Marketed Products. Responsibilities: develop risk-based audit strategies, conduct and manage audits of sites, vendors, and systems, handle inspection preparedness, lead investigations into GCP breaches, and facilitate regulatory inspections; communicate risks and findings to senior management. Requirements: BS/BA with 7+ years in pharma/biotech, at least 5 years in GCP QA or related clinical trial experience; extensive knowledge of ICH GCP R2 and global regulations; strong audit, investigation, and technical writing skills; certification in GCP QA preferred. High-Value: global GCP compliance, clinical trial audits, inspection readiness, investigation management, cross-functional stakeholder collaboration, 30% international travel, based remotely in USA (MA).