Senior Director, Global Clinical Quality & Excellence

Takeda; Cambridge (MA); On-site; USD 212,000 - 333,190; Full time

Job summary

Takeda USA in Cambridge, MA is seeking a Senior Director, Head of Clinical Program Quality & Excellence (TAU) to drive risk-based quality across therapeutic programs, strengthen regulatory confidence, and ensure inspection readiness.

You will lead the Clinical Program Quality & Excellence team to embed patient safety, data integrity, and global regulatory compliance across clinical trial delivery while influencing senior stakeholders and advancing enterprise quality strategies.

Qualifications

• 12+ years in the global pharmaceutical industry with 5+ years in Quality/Compliance.
• Advanced knowledge of clinical research and development across the product lifecycle.
• Deep expertise in GCP regulations, guidelines, and practical application.
• Experience leading quality oversight, audit programs, and CAPA.

Responsibilities

• Drive risk-based quality strategies across assigned clinical programs to ensure compliance, patient safety, and reduced development risk.
• Lead quality risk escalation, governance, and reporting with actionable insights for data-driven decisions.
• Oversee investigations of serious breaches and significant quality events with root-cause analysis and corrective actions.
• Ensure continuous inspection readiness and end-to-end regulatory compliance across programs.
• Lead global GCP inspection strategy and regulatory interactions as a clinical quality SME.
• Develop and execute risk-based audit strategies to mitigate quality risks across clinical development.
• Lead the CQ&E team to embed proactive quality oversight and cross-functional issue resolution.
• Partner with enterprise quality to drive organizational learning and improved trial delivery.
• Provide strategic counsel on complex quality challenges and resource planning.
• Build and retain a high-performing team with strong leadership and accountability.

Skills

Quality leadership

GCP expertise

Regulatory compliance

Risk management

Investigations & CAPA

Stakeholder engagement

Education

Master’s degree or PhD in a relevant field

Tools

Quality management systems

Job description

Takeda USA in Cambridge, MA is seeking a Senior Director, Head of Clinical Program Quality & Excellence (TAU) to drive risk-based quality across therapeutic programs, strengthen regulatory confidence, and ensure inspection readiness.

You will lead the Clinical Program Quality & Excellence team to embed patient safety, data integrity, and global regulatory compliance across clinical trial delivery while influencing senior stakeholders and advancing enterprise quality strategies.