Director, Clinical Program Quality and Excellence
Takeda
Summary
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.
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 improvement initiatives
- Strong understanding of quality-by-design principles and risk-based quality management approaches
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
- 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
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.