Associate Director, Clinical Program Quality and Excellence (Oncology)

Role: Senior Clinical Quality Assurance (QA) professional overseeing GCP compliance and inspection readiness across global clinical research programs in Takeda's R&D, PDT, VBU, OBU, and MPD units. Responsibilities include developing risk-based audit strategies, leading audit execution of sites, documents, and vendors, managing GCP health authority inspections, and investigating quality issues and scientific misconduct. The role serves as a strategic quality partner to clinical teams, providing expert guidance on GCP interpretation, training, and risk mitigation. Requirements: BA/BS (advanced degree preferred); at least 10 years in pharma/biotech, with 7+ years in GCP QA or clinical trials; extensive knowledge of ICH GCP, global regulations, and audit processes; strong technical writing, communication, and stakeholder management skills. Preferred: GCP QA certification. High-value specifics include experience with global clinical trials, investigator site inspections, and handling complex compliance issues; approximately 30% travel is expected. Location: virtual Massachusetts; reports to Head of Clinical Program Quality.