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

Note: The job is a remote job and is open to candidates in USA. Fortrea is a leading company in clinical pharmacology services, seeking an Executive Director for Quality Assurance and Regulatory Compliance. The role involves providing leadership for QA and compliance, developing quality management systems, and ensuring adherence to global regulatory standards across clinical pharmacology operations.ResponsibilitiesDefine and execute the QA strategy for the CPS business unit, aligned with enterprise quality objectives and business prioritiesEstablish and lead a risk-based quality management review process across CPS operations, including CPUs and supporting functionsDevelop CPS-specific quality metrics, dashboards, and insights to drive proactive risk identification and continuous improvementEnsure consistent interpretation and application of global regulations, including GCP and GMP requirements, within CPSProvide executive QA oversight of Clinical Pharmacology Units (CPUs), ensuring inspection readiness and compliance with GCP, GMP, and applicable regulatory standardsOversee QA frameworks governing GMP pharmacy operations within each CPU, including investigational product (IP) manufacturing, handling, labeling, storage, and accountabilityEnsure robust controls across pharmacy processes, including chain of custody, temperature control, documentation, and reconciliation practicesDrive standardization and continuous improvement of CPU and GMP pharmacy quality systems, ensuring alignment across global sitesSupport readiness for regulatory inspections and sponsor audits related to CPU and pharmacy operationsEstablish 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 modelsDevelop 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 modelsEnsure alignment with Clinical Operations, Medical, and SafetyEmbed quality-by-design principles into early-phase program design and executionProvide executive oversight of compliance risks, escalation, and remediation strategies across CPS and early-phase programsEnsure adherence to RC&QA governance requirements and controlled documentationServe as delegate within the RC&QA Leadership Team and contribute to enterprise governance forumsPartner with CPS and enterprise leadership to drive quality culture and executionInfluence strategic priorities and resource allocation aligned with CPS and early-phase deliveryRepresent Fortrea externally as an SME in clinical pharmacology, GMP pharmacy oversight, and early-phase qualityCommunicate quality strategy effectively to internal and external stakeholdersLead QA teams supporting CPUs, GMP pharmacies, and early-phase programsDevelop workforce strategy including recruitment, capability development, and succession planningDrive organizational change and continuous improvement aligned with evolving CPS delivery modelsProvide strong performance management, coaching, and leadership developmentPartner with stakeholders to manage QA budgets supporting CPSEnsure efficient delivery of QA services aligned with quality, cost, and timeline expectationsSkills15+ years of experience in a clinical trials regulated environment, including senior QA/Regulatory leadership rolesStrong expertise in GCP and GMP, particularly within clinical pharmacology and early-phase environmentsBachelor's degree in Life Sciences (or equivalent experience); advanced degree preferredProven ability to define and execute QA strategies in clinical pharmacology, CPU operations, and GMP-controlled environmentsExperience overseeing pharmacy operations supporting clinical trials (IP management under GMP)Demonstrated success leading global, matrixed teamsStrong executive presence with ability to influence internal and external stakeholdersExperience implementing risk-based quality oversight for early-phase trialsStrong track record in inspection readiness and regulatory engagementAdvanced degree preferredEquivalent experience may be considered in lieu of formal educationBenefitsMedicalDentalVisionLifeSTD/LTD401(K)ESPPPaid time off (PTO) or Flexible time off (FTO)Company bonus where applicableCompany OverviewFortrea is a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions. It was founded in 2023, and is headquartered in Durham, North Carolina, USA, with a workforce of 10001+ employees. Its website is https://www.fortrea.com.Company H1B SponsorshipFortrea has a track record of offering H1B sponsorships, with 6 in 2026, 14 in 2025, 25 in 2024, 6 in 2023. Please note that this does not guarantee sponsorship for this specific role.