Director, Clinical Program Quality and Excellence

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.

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, 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

Requirements

• 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

Qualifications

• Advanced scientific or healthcare degree (MS, PharmD, PhD, MD, or equivalent) preferred
• Experience supporting regulatory inspections and health authority interactions preferred
• Experience in clinical portfolio governance and risk management preferred
• Background in global clinical operations, pharmacovigilance, or quality systems preferred
• Experience leading complex remediation programs and continuous improvement initiatives preferred
• Strong understanding of quality-by-design principles and risk-based quality management approaches preferred

Skills

• Strategic thinking and problem-solving skills
• Effective communication and collaboration abilities
• Leadership and mentoring capabilities
• Technical expertise in clinical trials and quality management
• Ability to manage multiple priorities and deadlines

Benefits

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.