About the Role
As Director, Clinical Program Quality & Excellence (CPQE), TAU, you will provide strategic quality leadership across clinical assets, driving a risk-based quality management approach that enhances program performance, strengthens regulatory confidence, and supports faster delivery of innovative therapies to patients. You will influence key portfolio decisions by providing insights on emerging risks, critical quality issues, and mitigation strategies, while leading inspection readiness across Study Execution Teams and ensuring compliance with global GCP and regulatory expectations. Through strong partnership with senior stakeholders, you will champion a culture of quality by design, accountability, and scientific rigor that protects patient safety, ensures data integrity, and enables successful regulatory submissions worldwide. You will report into the Senior Director, CPQE.
How You Will Contribute
- Lead quality management for assigned asset-level clinical programs, developing and implementing proactive, risk-based quality strategies that drive compliance and reduce program risk
- Provide strategic oversight of quality risks, issues, and mitigation plans, escalating key insights to governance bodies to support data-driven, patient-centered decision making
- Direct investigations into Serious Breaches (GCP), Scientific Misconduct, and other significant quality events, applying robust root cause analysis to enable effective resolution and prevention of recurrence
- Drive inspection readiness across assigned clinical programs, ensuring sustainable compliance and quality oversight are embedded throughout the clinical trial lifecycle
- Shape and execute global GCP inspection strategies, leading preparation for submission-related inspections and serving as a subject matter expert during regulatory interactions
- Develop and implement risk-based audit strategies that enable early identification of quality concerns and proactive mitigation of clinical program risks
- Mentor and support CPQ team members aligned to Study Execution Teams (SETs), strengthening quality oversight capabilities and embedding real-time inspection readiness through proactive compliance and documentation excellence.
- Foster cross-functional collaboration to drive timely investigation and resolution of quality events while promoting a culture of continuous improvement
- Contribute to R&D Quality continuous improvement initiatives for Clinical Trial Delivery and PV Systems by sharing insights, lessons learned, and best practices across clinical programs
Skills and Qualifications
- Scientific or allied health/medical degree (BSc required; MSc or PhD preferred)
- Minimum of 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
