Senior Director, Clinical Quality & Excellence – Global QA

Regulatory Jobs; Cambridge (MA); In loco; USD 212.000 - 333.000; Tempo pieno

Descrizione del lavoro

Takeda seeks a Senior Director, Head of Clinical Program Quality & Excellence to drive risk-based quality management across global clinical programs. You will lead a team to ensure patient safety, data integrity, and regulatory compliance while engaging governance bodies and senior stakeholders.

The role requires 12+ years in pharma with 5+ years in quality/compliance, deep GCP knowledge, and a track record of inspection readiness and CAPA leadership. Cambridge, MA; full-time, on-site.

Competenze

• Bachelor's degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred.
• 12+ years in global pharma, with 5+ years in Quality/Compliance for clinical development.
• Deep knowledge of clinical research and development and GCP regulations.

Mansioni

• Drive risk-based quality strategies to ensure patient safety and regulatory compliance.
• Lead quality risk escalation, governance, and reporting with actionable insights.
• Oversee investigations of serious breaches and CAPA programs with root-cause analysis.
• Ensure inspection readiness and end-to-end compliance across clinical programs.
• Lead global GCP inspection strategy including submissions and agency interactions.
• Develop and execute risk-based audit strategies across clinical development.
• Lead the team embedding proactive quality oversight and cross-functional issue resolution.
• Partner with enterprise quality to strengthen trial delivery and pharmacovigilance systems.
• Provide strategic counsel on complex quality challenges and resource planning.
• Build and retain a high-performing team with strong leadership.

Conoscenze

Quality leadership

GCP knowledge

Regulatory inspections

Risk management

Data integrity

Patient safety

Formazione

Bachelor's in science

Master's or PhD preferred

Descrizione del lavoro

Takeda seeks a Senior Director, Head of Clinical Program Quality & Excellence to drive risk-based quality management across global clinical programs. You will lead a team to ensure patient safety, data integrity, and regulatory compliance while engaging governance bodies and senior stakeholders.

The role requires 12+ years in pharma with 5+ years in quality/compliance, deep GCP knowledge, and a track record of inspection readiness and CAPA leadership. Cambridge, MA; full-time, on-site.