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Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdo
- Durham, North Carolina, United States
- Durham, North Carolina, United States
Über
Leads the design, implementation, and continuous improvement of audit, inspection readiness, and quality oversight programs across CPS, including clinical pharmacology operations, GMP pharmacy activities, and early-phase clinical development, while fostering a strong culture of quality, compliance, and operational excellence.
Core Accountabilities CPS Quality Strategy & Oversight
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
Provide executive QA oversight of Clinical Pharmacology Units (CPUs), ensuring inspection readiness and compliance with GCP, GMP, and applicable regulatory standards
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
Provide executive oversight of compliance risks, escalation, and remediation strategies across CPS and early-phase programs
Ensure adherence to RC&QA governance requirements and controlled documentation
Serve as delegate within the RC&QA Leadership Team and contribute to enterprise governance forums Stakeholder Engagement & External Representation
Partner with CPS and enterprise leadership to drive quality culture and execution
Influence strategic priorities and resource allocation aligned with CPS and early-phase delivery
Represent Fortrea externally as an SME in clinical pharmacology, GMP pharmacy oversight, and early-phase quality
Communicate quality strategy effectively to internal and external stakeholders Organizational Leadership & Capability Building
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
Provide strong performance management, coaching, and leadership development Financial & Operational Management
Partner with stakeholders to manage QA budgets supporting CPS
Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectations 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
Bachelors degree in Life Sciences (or equivalent experience); advanced degree preferred
Equivalent experience may be considered in lieu of formal education Experience & Leadership Capabilities
Proven ability to define and execute QA strategies in clinical pharmacology, CPU operations, and GMP-controlled environments
Experience overseeing pharmacy operations supporting clinical trials (IP management under GMP)
Demonstrated success leading global, matrixed teams
Strong executive presence with ability to influence internal and external stakeholders
Experience implementing risk-based quality oversight for early-phase trials
Strong track record in inspection readiness and regulatory engagement Physical Demands / Work Environment
Ideally located at one of the Fortrea CPS units (Madison, WI - Dallas, TX - Daytona Beach, FL - Leeds, United Kingdom)
Travel to CPUs, GMP pharmacies, and global sites as required
*Flexibility for extended hours aligned with business and inspection needs Pay Range: $220,000-$245,000 (The range does not include benefits, and if applicable, bonus, commission, or equity)
Benefits: All job offers will be based on a candidates skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.
Application Deadline: June 10, 2026
Learn more about our
EEO & Accommodations request here
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Sprachkenntnisse
- English
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