Fortrea
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Be an Early Applicant
Provides executive leadership for Quality Assurance and Regulatory Compliance within Clinical Pharmacology Services, ensuring a robust quality management system and leading audit programs to promote compliance and operational excellence.
Summary of Responsibilities
Provides 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 & 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 CPSClinical 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 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 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 executionGovernance, 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 forumsStakeholder 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 stakeholdersOrganizational 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 developmentFinancial & Operational Management·Partner with stakeholders to manage QA budgets supporting CPS·Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectationsQualifications·Extensive 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 educationExperience & 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 engagementPhysical 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 needsLearn more about our EEO & Accommodations request here.
Similar Jobs
Digital Media • Gaming • Software • Esports • Automation
Design high-fidelity user experiences for a global gaming product. Responsibilities include translating concepts into cohesive designs, creating prototypes and user flows, maintaining style guides, collaborating with stakeholders and developers, presenting design rationale, researching design trends, and refining work based on feedback across digital platforms.
Top Skills:
FigmaSketch
Fintech • Mobile • Payments • Software • Financial Services
Lead data science for Wise’s AML Risk team by developing machine-learning and GenAI detection systems, optimizing precision-recall tradeoffs, building coverage frameworks, and deploying production Python services. Hire and mentor specialists, collaborate with product, engineering, and operations teams, design model evaluation experiments, improve operational processes, and create investigator insights for detecting financial crime across global transactions.
Top Skills:
Automated PipelinesGenerative AiLarge Language ModelsMachine LearningObject-Oriented ProgrammingPython
Artificial Intelligence • Big Data • Cloud • Information Technology • Software • Big Data Analytics • Automation
Draft, review, and negotiate enterprise SaaS, software licensing, services, reseller, vendor, DPA, NDA, and partner agreements. Advise Italy and UK sales and operations teams on commercial, intellectual property, licensing, revenue recognition, privacy, and related legal matters. Improve agreements and internal processes while providing practical, timely guidance and managing multiple priorities in a technology-focused business.
Top Skills:
AIAWSGCPAzureOn-Premises SoftwarePrivacy TechnologySaaS
What you need to know about the London Tech Scene
London isn't just a hub for established businesses; it's also a nursery for innovation. Boasting one of the most recognized fintech ecosystems in Europe, attracting billions in investments each year, London's success has made it a go-to destination for startups looking to make their mark. Top U.K. companies like Hoptin, Moneybox and Marshmallow have already made the city their base — yet fintech is just the beginning. From healthtech to renewable energy to cybersecurity and beyond, the city's startups are breaking new ground across a range of industries.
