Director of quality assurance Work, Jobs in Mexborough, Syk (with Salaries)

Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)
Fortrea —Leeds
- Full-time
- Bachelor's degree
- No degree
- Leadership

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Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)

Fortrea -
Leeds

Apply Now

Job details

Full-time

Qualifications

Bachelor's degree
Leadership

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

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 .

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director of quality assurance jobs in mexborough, syk

Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom)

Other jobs to consider

I want to receive the latest job alerts for director of quality assurance in mexborough, syk

Explore jobs in more locations

Core Accountabilities

CPS Quality Strategy & Oversight

Clinical Pharmacology, CPU & GMP Pharmacy Oversight

Phase IB/IIA Quality Oversight (Expanded Remit)

Governance, Risk & Compliance

Stakeholder Engagement & External Representation

Organizational Leadership & Capability Building

Financial & Operational Management

Qualifications

Experience & Leadership Capabilities

Physical Demands / Work Environment

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