Associate Director, Clinical Program Quality and Excellence (Oncology)

Role: Senior Clinical Quality Assurance Lead overseeing global clinical research programs within Takeda's R&D, Plasma Derived Therapy, Vaccines, Oncology, and Medical Marketed Products divisions. Objectives include ensuring inspection readiness, providing strategic quality guidance, and leading GCP compliance efforts. Responsibilities encompass developing risk-based audit strategies, managing site and vendor audits, leading GCP inspection readiness and responses, investigating quality issues, and facilitating regulatory audits and health authority inspections. Qualifications: BA/BS (advanced degree preferred), 10+ years in pharma/biotech, with 7+ years in GCP QA or clinical trials. Essential skills include deep knowledge of ICH GCP, global regulations, audit management, and risk mitigation. Preferred certifications include GCP QA registration. High-value specifics: expertise in clinical trial oversight, GCP compliance, and regulatory inspection management; experience with global audits, investigations, and cross-functional collaboration. Work setup: remote in Massachusetts with approximately 30% travel, including international.