Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United K[...]

Summary of Responsibilities Provides executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services business unit, ensuring a robust, risk‑based, inspection‑ready quality management system aligned with global regulatory expectations and the company strategy. Leads design, implementation, and continuous improvement of audit, inspection readiness and quality oversight programs across the unit, fostering a culture of quality, compliance and operational excellence. Core Accountabilities Define and execute the QA strategy for the business unit, aligned with enterprise quality objectives and priorities. Establish and lead a risk‑based quality management review process across operations. Develop unit‑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. Provide executive QA oversight of clinical pharmacology units (CPUs) and GMP pharmacy operations, ensuring inspection readiness and compliance. Oversee QA frameworks governing GMP pharmacy operations within each unit, including investigational product manufacturing, handling, labeling and accountability. Drive standardization and continuous improvement of quality systems, ensuring alignment across global sites. Support readiness for regulatory inspections and sponsor audits related to unit operations. Establish and lead a risk‑based quality oversight program for Phase IB/IIA trials conducted outside clinical sites. Develop fit‑for‑purpose QA frameworks addressing early‑phase risks and implement proactive surveillance mechanisms. Standardize processes and oversight across non‑clinic early‑phase delivery models and ensure alignment with clinical operations, medical, and safety. Embed quality‑by‑design principles into early‑phase program design and execution. Provide executive oversight of compliance risks, escalation and remediation strategies across programs. Ensure adherence to governance requirements and controlled documentation. Partner with leadership to drive quality culture and execution, influence strategic priorities, and represent the company externally as an SME in clinical pharmacology, GMP pharmacy oversight and early‑phase quality. Lead QA teams supporting CPUs, GMP pharmacies and early‑phase programs, develop workforce strategy and succession planning. Drive organizational change, continuous improvement and performance management. Partner with stakeholders to manage QA budgets and ensure efficient delivery of services. Qualifications 15+ years of experience in a clinical trials regulated environment, including senior QA/Regulatory leadership roles. Strong expertise in GCP and GMP, particularly within clinical pharmacology and early‑phase environments. Bachelor’s degree in Life Sciences (or equivalent experience); advanced degree preferred. Proven ability to define and execute QA strategies in clinical pharmacology, GMP‑controlled environments and lead global, matrixed teams. Experience overseeing pharmacy operations supporting clinical trials, with IP management under GMP. Strong executive presence and ability to influence internal and external stakeholders. Experience implementing risk‑based quality oversight for early‑phase trials. Track record of inspection readiness and regulatory engagement. Physical Demands and Travel Ideally located in one of the unit locations: Madison, WI; Dallas, TX; Daytona Beach, FL; Leeds, United Kingdom. Travel to CPU sites, GMP pharmacies and global locations as required. Flexibility for extended hours aligned with business and inspection needs. Compensation Pay range: $220,000–$245,000. Benefits are not included in the range. Benefits Medical, dental, vision, life, STD/LTD, 401(k), ESPP and paid time off. Company bonus where applicable. EEO Statement Learn more about our EEO and accommodations request. Application Deadline June 10, 2026 #J-18808-Ljbffr FTINC Fortrea Inc.