Global Clinical Quality & Program Excellence Leader

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda seeks a Senior Director, Head of Clinical Program Quality & Excellence to drive risk-based quality leadership across Therapeutic Area Unit clinical programs. You will guide governance, patient safety, data integrity, and regulatory readiness while partnering with enterprise quality teams to advance quality strategies and improve study delivery.

You will lead investigations, CAPA programs, and external inspections, shaping a culture of quality by design and accountability within a global

Qualifications

• Bachelor’s degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred.
• 12+ years in the global pharmaceutical industry, including 5+ years in Quality/Compliance supporting clinical development programs.
• Advanced knowledge of clinical research and development across the product lifecycle.

Responsibilities

• Drive risk-based quality strategies across 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, scientific misconduct, and significant quality events with root cause analysis and corrective actions.
• Ensure continuous inspection readiness and end-to-end regulatory compliance across clinical programs.
• Lead global GCP inspection strategy, including submission-related inspections and agency interactions as a quality SME.
• Develop and execute risk-based audit strategies to identify and mitigate quality risks across clinical development programs.
• Lead the Clinical Program Quality & Excellence team, embedding proactive quality oversight and cross-functional issue resolution.
• Provide strategic counsel on complex quality challenges, priorities, and resource planning to the Head of CPMQ.
• Build and retain a high-performing team through leadership, talent development, and accountability culture.

Skills

Quality management

GCP regulations

Regulatory inspections

Risk-based approach

Cross-functional leadership

Patient safety

Data integrity

CAPA programs

Audit programs

Governance

Education

Bachelor’s degree in a scientific/medical/health-related field

Master’s or PhD preferred

Job description

Takeda seeks a Senior Director, Head of Clinical Program Quality & Excellence to drive risk-based quality leadership across Therapeutic Area Unit clinical programs. You will guide governance, patient safety, data integrity, and regulatory readiness while partnering with enterprise quality teams to advance quality strategies and improve study delivery.

You will lead investigations, CAPA programs, and external inspections, shaping a culture of quality by design and accountability within a global