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 Quality Assurance and Regulatory Compliance. The role involves providing executive leadership for QA and compliance, ensuring a robust quality management system, and overseeing quality strategies across clinical pharmacology operations.
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
- 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); advanced degree preferred
- Equivalent experience may be considered in lieu of formal education
- 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
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