Executive Director, Clinical Pharmacology Services Quality Assurance

Fortrea; Ledston; On-site; GBP 150,000 - 190,000; Full time

Job summary

Fortrea in Leeds, United Kingdom, seeks an executive QA leader to drive quality strategy across Clinical Pharmacology Units, GMP pharmacy operations, and early-phase programs. You will lead risk-based oversight, ensure inspection readiness, and champion a culture of quality and regulatory excellence.

You will collaborate with Clinical Operations, Medical, and Safety to align quality governance with CPS delivery, while guiding global teams and stakeholders through continuous improvement

Qualifications

• 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; advanced degree preferred. Equivalent experience may be considered.

Responsibilities

• Provide executive QA leadership for CPS, ensuring inspection readiness and compliance with GCP, GMP, and regulatory standards.
• Oversee QA frameworks for GMP pharmacy operations within CPUs, including IP handling, labeling, storage and accountability.
• Lead risk-based quality oversight for Phase IB/IIA trials outside CPS clinics with decentralized/early-phase models.
• Drive standardization and continuous improvement of CPU and GMP pharmacy quality systems across global sites.
• Embed quality-by-design principles into early-phase program design and execution.
• Partner with stakeholders to manage QA budgets and ensure timely delivery of services.

Skills

QA strategy

GCP & GMP

Regulatory leadership

Executive presence

Stakeholder engagement

Education

Bachelor’s degree in Life Sciences

Advanced degree preferred

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

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 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

Learn more about our EEO & Accommodations request here.

At Fortrea, we're all about turning the "impossible" into "I'm possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we're all family, working together to achieve extraordinary results. At Fortrea, your career isn't just a job – it's a journey of making the exceptional possible, every day.