Strategic Director, Clinical Quality & Excellence

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

Job summary

Takeda seeks a Director, CPQE to shape risk-based quality management across clinical programs, ensuring inspection readiness, regulatory compliance, and proactive oversight throughout trials. You will partner with global teams to identify risks, drive resolution, and safeguard patient safety and data integrity.

Lead quality services for asset governance, supervise investigations into major quality events, and mentor CPQE professionals to embed quality-by-design and continuous improvement across

Qualifications

• Bachelor's degree in a scientific, medical, healthcare, or related discipline.
• 10+ years of experience within the pharmaceutical, biotechnology, or healthcare industry.
• At least 5 years of experience in Quality, Compliance, Clinical Development Quality, or related functions.
• Deep knowledge of Good Clinical Practice (GCP) regulations, quality systems, and clinical trial processes.
• Experience supporting global clinical development programs from study start-up through regulatory submission.
• Demonstrated 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 with senior leaders.
• Excellent communication, leadership, and organizational skills.

Responsibilities

• Lead quality management activities for assigned clinical development programs, implementing proactive and risk-based quality oversight strategies.
• Serve as a strategic quality advisor to asset-level governance bodies, including Global Program Teams and Clinical Review Boards.
• Drive identification, escalation, and mitigation of quality risks and critical issues to support patient-centric decisions.
• Lead investigations into significant quality events, including GCP breaches and major compliance deviations.
• Develop and execute inspection readiness strategies ensuring ongoing compliance throughout trial execution.
• Lead global GCP inspection planning and preparation activities as SME during regulatory interactions.
• Design and implement risk-based audit strategies to proactively identify quality and compliance risks.
• Partner with Study Execution Teams to strengthen quality oversight models and real-time inspection readiness.

Skills

Quality leadership

GCP regulations

Regulatory affairs

Risk management

Stakeholder engagement

Investigations

Inspection readiness

Quality systems

Communication skills

Project coordination

Education

Bachelor's degree

Advanced degree preferred

Job description

Takeda seeks a Director, CPQE to shape risk-based quality management across clinical programs, ensuring inspection readiness, regulatory compliance, and proactive oversight throughout trials. You will partner with global teams to identify risks, drive resolution, and safeguard patient safety and data integrity.

Lead quality services for asset governance, supervise investigations into major quality events, and mentor CPQE professionals to embed quality-by-design and continuous improvement across