Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)

Responsibilities

• Define and execute the QA strategy for the CPS business unit, aligned with enterprise quality objectives and business priorities
• Establish and lead a risk-based quality management review process across CPS operations, including CPUs and supporting functions
• Develop CPS-specific quality metrics, dashboards, and insights to drive proactive risk identification and continuous improvement
• Ensure consistent interpretation and application of global regulations, including GCP and GMP requirements, within CPS Clinical Pharmacology, CPU & GMP Pharmacy Oversight
• Oversee QA frameworks governing GMP pharmacy operations within each CPU, including investigational product (IP) manufacturing, handling, labeling, storage, and accountability
• Ensure robust controls across pharmacy processes, including chain of custody, temperature control, documentation, and reconciliation practices
• Drive standardization and continuous improvement of CPU and GMP pharmacy quality systems, ensuring alignment across global sites
• Support readiness for regulatory inspections and sponsor audits related to CPU and pharmacy operations Phase IB/IIA Quality Oversight (Expanded Remit)
• Establish and lead a risk-based quality oversight program for Phase IB/IIA trials conducted outside CPS clinics, including decentralized, hybrid, and site-based early-phase models
• Develop fit-for-purpose QA frameworks addressing early-phase risks (FIH, dose escalation, adaptive designs)
• Implement proactive surveillance mechanisms (targeted audits, real-time quality signals, risk indicators)
• Standardize processes and oversight across non-clinic early-phase delivery models
• Ensure alignment with Clinical Operations, Medical, and Safety
• Embed quality-by-design principles into early-phase program design and execution Governance, Risk & Compliance
• Ensure adherence to RC&QA governance
• Influence strategic priorities and resource allocation aligned with CPS and early-phase delivery
• Lead QA teams supporting CPUs, GMP pharmacies, and early-phase programs
• Develop workforce strategy including recruitment, capability development, and succession planning
• Drive organizational change and continuous improvement aligned with evolving CPS delivery models
• Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectations