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. The role shapes and executes risk-based quality management strategies across assigned clinical programs, ensuring inspection readiness, regulatory compliance, and proactive quality oversight throughout the clinical trial lifecycle. The Director partners 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. The position supports portfolio decision-making, patient safety, data integrity, and successful regulatory submissions worldwide. The role also contributes to R&D Quality continuous improvement initiatives and mentors Clinical Program Quality professionals, promoting accountability, quality by design, and continuous improvement.
Requirements
- Bachelor's degree in a scientific, medical, healthcare, or related discipline.
- 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 and implement proactive, 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.
- Identify, escalate, and mitigate 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 to ensure sustainable compliance throughout clinical trial execution.
- Lead global GCP inspection planning and preparation, serving as a subject matter expert during regulatory interactions and inspections.
- Design and implement risk-based audit strategies to 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 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Director
