Note: The job is a remote job and is open to candidates in USA. Fortrea is a company focused on clinical pharmacology services, and they are seeking an Executive Director for Clinical Pharmacology Services Quality Assurance. The role involves providing leadership for quality assurance and regulatory compliance, leading quality oversight programs, and ensuring adherence to global regulations.
Responsibilities
- Provide executive leadership for Quality Assurance (QA) and Regulatory Compliance within the Clinical Pharmacology Services (CPS) business unit, ensuring a robust, risk-based, and inspection-ready quality management system aligned with global regulatory expectations and Fortrea business strategy
- Lead 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
- 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
- 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
- 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
- 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
- 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
- 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
- Partner with stakeholders to manage QA budgets supporting CPS
- Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectations
Skills
- 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)
- 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
- Advanced degree preferred
- Equivalent experience may be considered in lieu of formal education
Benefits
- Medical
- Dental
- Vision
- Life
- STD/LTD
- 401(K)
- ESPP
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
Company Overview
Company H1B Sponsorship