Director, Clinical Program Quality and Excellence
About The Position
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.
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
Nice To Haves
- 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
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
Benefits
- 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
- well-being benefits
- up to 80 hours of sick time per calendar year
- up to 120 hours of paid vacation for new hires
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What This Job Offers
Job Type
Full-time
Career Level
Director
