At a Glance
- Tasks: Lead Quality Assurance and Regulatory Compliance for Clinical Pharmacology Services, ensuring top-notch quality management.
- Company: Fortrea, a leader in clinical pharmacology with a commitment to quality and compliance.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Other info: Dynamic work environment with opportunities for travel and global collaboration.
- Why this job: Make a significant impact on clinical trials and ensure the highest standards of quality.
- Qualifications: Extensive experience in QA roles within clinical trials and strong knowledge of GCP and GMP.
The predicted salary is between 80000 - 100000 £ per year.
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.
Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom) in Leeds employer: Fortrea
Fortrea is an exceptional employer that fosters a dynamic and collaborative work culture in Maidenhead, England. With a strong emphasis on employee growth and development, we offer comprehensive training programs and opportunities for advancement within the pharmaceutical sector. Our commitment to innovation and client success ensures that you will play a pivotal role in shaping the future of healthcare while enjoying a supportive environment that values your contributions.
StudySmarter Expert Advice🤫
We think this is how you could land Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom) in Leeds
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We think you need these skills to ace Executive Director, Clinical Pharmacology Services Quality Assurance (United States or United Kingdom) in Leeds
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Fortrea!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Fortrea that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Fortrea!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Fortrea, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Fortrea
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Fortrea that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Fortrea’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
