Director, Clinical Quality & Regulatory Readiness

Regulatory Jobs; Boston (MA); Presencial; USD 177.000 - 278.000; Tempo integral

Resumo da vaga

Takeda seeks a Director, Clinical Program Quality to shape a proactive, risk-based quality management strategy across clinical assets, strengthening regulatory confidence and accelerating time to market.

You will lead real-time inspection readiness, guide governance forums, mentor teams, and drive quality by design across the trial lifecycle, reporting to the Head of Clinical Program Quality, Gastrointestinal and Inflammation. Boston, MA salary range listed.

Qualificações

• Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
• 10+ years of progressive experience in the global pharmaceutical industry, including at least 5 years in Quality and/or Compliance supporting clinical development programs
• Advanced expertise across the clinical development lifecycle, from R&D through commercialization and lifecycle management, with deep, hands-on knowledge of GCP regulations and guidelines
• Experience in quality leadership roles, including quality systems oversight, clinical portfolio governance, audit programs, global regulatory inspection management, and complex investigation and remediation activities

Responsabilidades

• Develop and execute proactive, risk-based quality management strategies across assigned clinical development assets to strengthen compliance, reduce risk, and enhance overall program performance
• Provide strategic quality leadership by elevating critical quality issues, emerging risks, and mitigation plans to governance bodies, enabling informed, patient-centered, and data-driven decision making
• Lead investigations of Serious Breaches (GCP), scientific misconduct, and other significant quality events, applying robust root cause analysis and driving sustainable corrective and preventive actions
• Drive end-to-end inspection readiness across assigned clinical programs, embedding quality oversight and sustainable compliance throughout the clinical trial lifecycle
• Shape and execute global GCP inspection strategies, leading preparation for regulatory inspections and serving as a clinical program quality subject matter expert during health authority interactions
• Design and implement risk-based audit strategies that enable the early identification of quality concerns and proactive mitigation of clinical program risks
• Mentor and support Clinical Program Quality team members and Study Execution Teams, strengthening quality oversight capabilities, documentation excellence, proactive compliance, and cross-functional resolution of quality events
• Advance continuous improvement across R&D Quality by sharing insights, best practices, and lessons learned to enhance quality, performance, and operational excellence across Clinical Trial Delivery and Pharmacovigilance

Conhecimentos

Clinical quality leadership

Clinical development lifecycle

GCP expertise

Quality systems oversight

Formação

BSc (required)

MSc or PhD preferred

Descrição da vaga

Takeda seeks a Director, Clinical Program Quality to shape a proactive, risk-based quality management strategy across clinical assets, strengthening regulatory confidence and accelerating time to market.

You will lead real-time inspection readiness, guide governance forums, mentor teams, and drive quality by design across the trial lifecycle, reporting to the Head of Clinical Program Quality, Gastrointestinal and Inflammation. Boston, MA salary range listed.