Associate Director, Clinical Program Quality and Excellence; Oncology
Listed on 2026-10-09
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Quality Assurance - QA/QC
Regulatory Compliance Specialist
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.
ObjectivesEnsuring inspection readiness, providing strategic quality guidance, and leading GCP compliance efforts.
ResponsibilitiesDeveloping 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.
QualificationsBA/BS (advanced degree preferred), 10+ years in pharma/biotech, with 7+ years in GCP QA or clinical trials.
Essential SkillsDeep knowledge of ICH GCP, global regulations, audit management, and risk mitigation.
Preferred CertificationsGCP QA registration.
High-value specificsExpertise in clinical trial oversight, GCP compliance, and regulatory inspection management; experience with global audits, investigations, and cross-functional collaboration.
Work setupRemote in Massachusetts with approximately 30% travel, including international.
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