15+ years of experience in clinical trials in QA/Regulatory leadership roles
Expertise in GCP and GMP within clinical pharmacology
Bachelor’s degree in Life Sciences (advanced degree preferred)
Strong track record in inspection readiness and regulatory engagement
Proven ability to define and execute QA strategies
Responsibilities
Define and execute the QA strategy for the CPS business unit
Establish and lead a risk-based quality management process
Develop CPS-specific quality metrics and insights for improvement
Ensure compliance with GCP and GMP regulations
Lead QA oversight of Clinical Pharmacology Units and GMP pharmacy operations
Establish risk-based oversight for Phase IB/IIA trials
Engage with stakeholders to drive quality culture and execution
Benefits
Comprehensive Medical, Dental, Vision, Life Insurance
Short-term and Long-term Disability plans
401(K) retirement plan
Employee Stock Purchase Plan (ESPP)
Flexible or Paid Time Off (PTO)
Opportunity for company bonus where applicable
Full Job Description
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 Accountabilities
CPS 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 CPS
Clinical 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 operations
Phase 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 execution
Governance, 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 forums
Stakeholder 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 stakeholders
Organizational 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 development
Financial & Operational Management ·Partner with stakeholders to manage QA budgets supporting CPS ·Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectations
Qualifications ·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
Experience & 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 engagement
Physical 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 needs
Pay 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.
