Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
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The Role
The Executive Director provides leadership for Quality Assurance and Regulatory Compliance in Clinical Pharmacology Services, ensuring a quality management system aligned with regulations and business strategy. Responsibilities include overseeing QA audits, compliance risks, and employee management, while fostering a culture of quality and operational excellence.
Summary Generated by Built In
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 & 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·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 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 needsPay Range: $220,000-$245,000 (The range does not include benefits, and if applicable, bonus, commission, or equity)
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.Application Deadline: September 30, 2026
Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), and Company bonus where applicable. For more detailed information, please click here.Application Deadline: September 30, 2026
Learn more about our EEO & Accommodations request here.
Skills Required
- ~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
- Demonstrated success leading global, matrixed teams
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The Company
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
