Director, Clinical Quality & Risk Management

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

Benefits offered by this job

Job summary

Takeda seeks a Director of Clinical Program Quality to lead a proactive, risk-based quality strategy across clinical assets and ensure robust regulatory submission readiness. You will guide governance forums, drive investigations, and champion quality by design to protect patient safety and program value.

You will collaborate with Study Execution Teams and functional partners to embed continuous improvement and compliance across the lifecycle, from development through commercialization,

Qualifications

• Advanced knowledge of GCP regulations and guidelines.
• Experience leading quality systems and regulatory inspections.
• Ability to communicate with senior leadership and drive remediation.

Responsibilities

• Develop and lead proactive, risk-based quality management strategies across clinical development assets.
• Elevate critical quality issues and mitigation plans to governance bodies.
• Lead investigations of Serious Breaches (GCP) and other significant quality events.
• Drive end-to-end inspection readiness across clinical programs.
• Shape global GCP inspection strategies and interact with health authorities.
• Design risk-based audit strategies for early quality issue identification.
• Mentor team members to strengthen quality oversight and cross-functional resolution.
• Share insights to advance continuous improvement across R&D Quality.

Skills

Quality leadership

GCP compliance

Regulatory inspection management

Risk-based quality management

Root cause analysis

Education

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

Job description

Takeda seeks a Director of Clinical Program Quality to lead a proactive, risk-based quality strategy across clinical assets and ensure robust regulatory submission readiness. You will guide governance forums, drive investigations, and champion quality by design to protect patient safety and program value.

You will collaborate with Study Execution Teams and functional partners to embed continuous improvement and compliance across the lifecycle, from development through commercialization,