Director, Oncology Clinical Quality & Excellence

Takeda; Cambridge (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda in Cambridge, MA is seeking a Director of Clinical Program Quality & Excellence (CPQE), Oncology to lead asset-level quality management and inspection readiness. You will drive risk-based quality controls, governance discussions, and proactive issue resolution across global programs to safeguard patient safety and regulatory success.

You will partner with senior stakeholders, mentor CPQ teams, and shape strategies spanning R&D through lifecycle management, ensuring robust compliance and

Qualifications

• 10+ years in the global pharmaceutical industry with at least 5 years in quality/compliance for clinical programs.
• Deep knowledge of GCP regulations and guidelines across development lifecycle.
• Experience in quality leadership, governance, audits and regulatory inspections.

Responsibilities

• Shape asset-level risk-based quality management to reduce systemic compliance risks.
• Lead quality issues escalation for data-driven, patient-centric decisions at governance bodies.
• Drive real-time inspection readiness across Study Execution Teams and QA oversight.
• Lead global GCP inspection strategy and support regulatory interactions as SME.
• Develop and implement robust audit strategies to mitigate program risks.

Skills

Quality leadership

GCP knowledge

Regulatory compliance

Risk management

Cross-functional leadership

Inspection readiness

Executive presence

Data-driven decision making

Education

BSc required

MSc or PhD preferred

Job description

Takeda in Cambridge, MA is seeking a Director of Clinical Program Quality & Excellence (CPQE), Oncology to lead asset-level quality management and inspection readiness. You will drive risk-based quality controls, governance discussions, and proactive issue resolution across global programs to safeguard patient safety and regulatory success.

You will partner with senior stakeholders, mentor CPQ teams, and shape strategies spanning R&D through lifecycle management, ensuring robust compliance and