Director, Clinical Quality & Excellence – Oncology

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Company seeks a Director, Clinical Program Quality & Excellence (CPQE), Oncology, based in Cambridge, MA. You will lead asset-level quality governance, drive risk-based quality management, and ensure inspection readiness across Study Execution Teams.

You will mentor CPQ teams, shape global GCP compliance, and partner with senior stakeholders to safeguard patient safety and data integrity while supporting regulatory submissions worldwide.

Qualifications

• Advanced expertise in quality and compliance supporting clinical development programs.
• Experience leading quality systems oversight, audit programs, and regulatory inspection management.
• Strong interpersonal skills with executive presence and ability to influence senior stakeholders.

Responsibilities

• Develop and implement risk-based quality management strategies for asset-level programs.
• Lead investigations into quality events and enable root-cause analysis and preventive actions.
• Oversee global GCP inspection strategy and submission-related inspections.
• Mentor CPQ team and contribute to continuous improvement initiatives.

Skills

Strategic leadership

Quality assurance

GCP knowledge

Regulatory compliance

Cross-functional collaboration

Issue investigation

Education

Scientific or allied health/medical degree

Job description

Takeda Pharmaceutical Company seeks a Director, Clinical Program Quality & Excellence (CPQE), Oncology, based in Cambridge, MA. You will lead asset-level quality governance, drive risk-based quality management, and ensure inspection readiness across Study Execution Teams.

You will mentor CPQ teams, shape global GCP compliance, and partner with senior stakeholders to safeguard patient safety and data integrity while supporting regulatory submissions worldwide.