Director of Clinical Quality & Inspection Excellence

Takeda Pharmaceutical Co.; Boston (MA); On-site; USD 177,000 - 278,000; Full time

Job summary

Takeda Pharmaceutical Co. is seeking a Director of Clinical Program Quality & Excellence to shape risk-based quality management across clinical programs.

You will partner with Clinical Development, Regulatory, and Quality teams to identify risks, drive issues to resolution, and ensure data integrity and patient safety through the lifecycle. You will lead investigations into quality events, drive inspection readiness, and support regulatory submissions worldwide, while mentoring teams and

Qualifications

• Bachelor's degree in a scientific, medical, healthcare, or related discipline required.
• 10+ years of experience in pharma/biotech/healthcare industry.
• At least 5 years in Quality, Compliance, Clinical Development Quality, or related functions.
• Deep knowledge of GCP regulations, quality systems, and clinical trial processes.
• Experience supporting global clinical development programs from study start-up through regulatory submission.
• Experience leading quality oversight, inspection readiness, audit programs, and compliance initiatives.
• Strong investigation and root cause analysis experience related to quality events and compliance issues.
• Proven ability to influence and partner effectively with senior leaders and cross-functional stakeholders.
• Excellent communication, leadership, and organizational skills.

Responsibilities

• Lead quality management activities for assigned clinical development programs with proactive, risk-based oversight.
• Serve as a strategic quality advisor to asset-level governance bodies.
• Drive identification, escalation, and mitigation of quality risks and critical issues.
• Lead investigations into significant quality events, including GCP breaches and compliance deviations.
• Develop and execute inspection readiness strategies for ongoing clinical trials.
• Lead global GCP inspection planning and regulatory interactions as SME.
• Design and implement risk-based audit strategies to mitigate quality risks.
• Partner with Study Execution Teams to strengthen quality oversight and real-time readiness.
• Mentor Clinical Program Quality professionals and foster continuous improvement.
• Drive cross-functional issue resolution and adoption of best practices across programs.
• Share lessons learned and quality trends to improve organizational performance.
• Influence senior stakeholders to strengthen compliance and protect patient safety.

Skills

Leadership

Communication

Cross-functional partnering

Risk-based quality management

Investigation & root cause

Inspection readiness

Quality oversight

Education

Bachelor's degree in science/healthcare

Job description

Takeda Pharmaceutical Co. is seeking a Director of Clinical Program Quality & Excellence to shape risk-based quality management across clinical programs.

You will partner with Clinical Development, Regulatory, and Quality teams to identify risks, drive issues to resolution, and ensure data integrity and patient safety through the lifecycle. You will lead investigations into quality events, drive inspection readiness, and support regulatory submissions worldwide, while mentoring teams and