Director, Clinical Quality & Inspection Readiness

Takeda Pharmaceutical Co.; United States; Sur place; USD 177 000 - 278 000; Plein temps

Résumé du poste

The Director, Clinical Program Quality & Excellence (CPQE) at Takeda leads risk-based quality management across the clinical development portfolio, ensuring inspection readiness, data integrity, and regulatory compliance throughout trials. The role partners with global Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality to reinforce patient safety and drive continuous improvement.

Responsibilities include leading quality oversight, investigations of major quality events,

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.
• Proven ability to influence and partner effectively with senior leaders and cross-functional stakeholders.
• Excellent communication, leadership, and organizational skills.

Responsabilités

• 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

Formation

Bachelor's degree in a scientific, medical, healthcare, or related discipline

Advanced scientific or healthcare degree

Description du poste

The Director, Clinical Program Quality & Excellence (CPQE) at Takeda leads risk-based quality management across the clinical development portfolio, ensuring inspection readiness, data integrity, and regulatory compliance throughout trials. The role partners with global Clinical Development, Study Execution Teams, Regulatory Affairs, and Quality to reinforce patient safety and drive continuous improvement.

Responsibilities include leading quality oversight, investigations of major quality events,