Director, Clinical Program Quality and Excellence

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Job Description

About the role

The Director, Clinical Program Quality & Excellence (CPQE) serves as a strategic quality leader supporting Takeda’s clinical development portfolio. This role is responsible for shaping and executing risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle.

You will partner closely with global cross-functional stakeholders, including Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality organizations, to identify emerging risks, drive issue resolution, and strengthen quality performance across clinical programs. This position plays a critical role in supporting portfolio decision-making, safeguarding patient safety, ensuring data integrity, and enabling successful regulatory submissions worldwide.

How you will contribute

• 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, Clinical Sub-Teams, and Clinical Review Boards

• Drive identification, escalation, and mitigation of quality risks and critical issues to support informed, patient-centric decision-making

• Lead investigations into significant quality events, including GCP Serious Breaches, scientific misconduct, and major compliance deviations

• Develop and execute inspection readiness strategies, ensuring sustainable compliance throughout clinical trial execution

• Lead global GCP inspection planning and preparation activities, serving as a subject matter expert during regulatory interactions and inspections

• Design and implement risk-based audit strategies to proactively identify and mitigate quality and compliance risks

• Partner with Study Execution Teams to strengthen quality oversight models and embed real-time inspection readiness practices

• Mentor and support Clinical Program Quality professionals, fostering a culture of accountability, quality by design, and continuous improvement

• Drive cross-functional issue resolution and promote adoption of best practices across clinical development programs

• Contribute to R&D Quality continuous improvement initiatives by sharing lessons learned, inspection insights, and quality trends across the organization

• Influence senior stakeholders to strengthen compliance, improve operational effectiveness, and protect patient safety and data integrity

What you bring to Takeda

Required Qualifications

• Bachelor's degree in a scientific, medical, healthcare, or related discipline required

• Minimum 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 effectively with senior leaders and cross-functional stakeholders

• Excellent communication, leadership, and organizational skills

Preferred Qualifications

• Advanced scientific or healthcare degree (MS, PharmD, PhD, MD, or equivalent)

• Experience supporting regulatory inspections and health authority interactions

• Experience in clinical portfolio governance and risk management

• Background in global clinical operations, pharmacovigilance, or quality systems

• Experience leading complex remediation programs and continuous im