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. 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.

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

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

About Takeda

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best-in-class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Pay

For Location: Boston, MA, the U.S. base salary range is $177,000.00 - $278,080.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

Benefits

• Eligibility for short-term and/or long-term incentives
• Medical, dental, and vision insurance
• 401(k) plan with company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits
• Up to 80 hours of sick time per calendar year
• New hires eligible to accrue up to 120 hours of paid vacation

Locations: Boston, MA

Worker Type: Employee, Full time, Exempt