About the Role
As the Senior Director, Head of Clinical Program Quality & Excellence (TAU), you will drive a risk-based quality management approach across the Therapeutic Area Unit, strengthening clinical program performance, regulatory confidence, and inspection readiness. You will provide quality leadership to key governance bodies, identify and mitigate emerging risks, and lead the Clinical Program Quality & Excellence team to embed operational excellence, patient safety, data integrity, and global regulatory compliance across clinical trial delivery. Additionally, you will help advance enterprise quality strategies, influence senior stakeholders, and foster a culture of quality by design, accountability, and continuous improvement. You will report into the Vice President, Head of Clinical, Pharmacovigilance and Medical Quality (CPMQ).
How You Will Contribute
- Drive risk-based quality strategies across assigned clinical programs to ensure compliance, patient safety, and reduced development risk
- Lead quality risk escalation, governance, and reporting, providing actionable insights to support timely, data-driven decisions
- Oversee investigations of serious breaches, scientific misconduct, and significant quality events, ensuring effective root cause analysis and sustainable corrective actions
- Ensure continuous inspection readiness and end-to-end compliance across clinical programs
- Lead global GCP inspection strategy, including submission-related inspections and regulatory agency interactions as a clinical quality SME
- Develop and execute risk-based audit strategies to identify, assess, and mitigate quality risks across clinical development programs
- Lead the Clinical Program Quality & Excellence team, embedding proactive quality oversight, inspection readiness, and cross-functional issue resolution across Study Execution Teams
- Partner with enterprise quality and continuous improvement teams to drive organizational learning and strengthen clinical trial delivery and pharmacovigilance systems
- Provide strategic counsel to the Head of CPMQ on complex quality challenges, priorities, initiatives, and resource planning
- Build, develop, and retain a high-performing team through strong leadership, talent development, succession planning, and a culture of accountability
Skills and Qualifications
- Bachelor’s degree in a scientific, medical, health-related, or equivalent discipline; Master’s or PhD preferred
- 12+ years of experience in the global pharmaceutical industry, including 5+ years in Quality and/or Compliance supporting clinical development programs
- Advanced knowledge of clinical research and development across the product lifecycle, including development, commercialization, and lifecycle management
- Deep expertise in GCP regulations, guidelines, and their practical application
- Experience in clinical portfolio quality oversight, global quality systems, audit programs, regulatory inspections, and quality risk management
- Experience leading complex investigations, remediation activities, and corrective and preventive action (CAPA) programs
- Expertise in developing and implementing risk-based quality management and audit strategies
- Experience supporting health authority inspections and submission-related regulatory activities
- Knowledge of clinical trial quality systems, inspection readiness, and compliance oversight frameworks
- Experience leading enterprise transformation initiatives, including quality system integration, operating model evolution, and outsourcing strategies
- Experience managing global quality organizations and developing high-performing teams
- Understanding of Pharmacovigilance, Medical Quality, and Clinical Quality processes and systems
- Commitment to patient safety, data integrity, scientific rigor, and regulatory compliance
About Us
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.
