Director, Oncology Clinical Quality & Excellence

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

Job summary

Takeda in Cambridge, MA seeks a Director, Clinical Program Quality & Excellence (CPQE), Oncology, reporting to the Head of CPQ Oncology. This role leads asset-level quality management, inspection readiness, and regulatory strategy to ensure patient safety and timely submissions.

The successful candidate will drive risk-based quality systems, govern global GCP compliance, mentor CPQ teams, and partner with senior stakeholders across research, development, and regulatory affairs.

Qualifications

• Scientific or allied health/medical degree at minimum (BSc).
• 10+ years in global pharma with 5+ years in quality/compliance for clinical development.
• Deep knowledge of GCP regulations and global regulatory expectations.
• Experience in quality leadership, audit programs and regulatory inspections.

Responsibilities

• Develop proactive, risk-based quality management strategies for assets.
• Lead quality issues escalations and governance level decision-making.
• Oversee investigations into Serious Breaches and root cause analyses.
• Drive inspection readiness and global GCP inspection strategy.
• Mentor CPQ teams and support cross-functional quality oversight.
• Contribute to continuous improvement in R&D Quality GxP initiatives.

Skills

GCP knowledge

Quality leadership

Regulatory compliance

Executive communication

Education

Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)

Job description

Takeda in Cambridge, MA seeks a Director, Clinical Program Quality & Excellence (CPQE), Oncology, reporting to the Head of CPQ Oncology. This role leads asset-level quality management, inspection readiness, and regulatory strategy to ensure patient safety and timely submissions.

The successful candidate will drive risk-based quality systems, govern global GCP compliance, mentor CPQ teams, and partner with senior stakeholders across research, development, and regulatory affairs.