Executive QA & Regulatory Lead, Clinical Pharmacology

Summary of ResponsibilitiesProvides 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.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 AccountabilitiesCPS Quality Strategy & OversightDefine 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 CPSClinical Pharmacology, CPU & GMP Pharmacy OversightProvide 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 operationsPhase 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 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 executionGovernance, Risk & ComplianceProvide 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 forumsStakeholder Engagement & External RepresentationPartner 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 stakeholdersOrganizational Leadership & Capability BuildingLead 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 developmentFinancial & Operational ManagementPartner with stakeholders to manage QA budgets supporting CPSEnsure efficient delivery of QA services aligned with quality, cost, and timeline expectationsQualificationsExtensive 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 preferredEquivalent experience may be considered in lieu of formal educationExperience & Leadership CapabilitiesProven 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 engagementPhysical Demands / Work EnvironmentIdeally 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 requiredFlexibility for extended hours aligned with business and inspection needsLearn more about our EEO & Accommodations request here .#J-18808-Ljbffr…