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.
- 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.
- 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.
- 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 prioritises a culture of quality, compliance, and operational excellence within the Clinical Pharmacology Services (CPS) business unit. With a strong commitment to employee growth, we offer extensive training and development opportunities, ensuring our team members are equipped to lead in a dynamic regulatory environment. Located in vibrant cities like Leeds, our employees enjoy a collaborative work atmosphere, competitive benefits, and the chance to make a meaningful impact in clinical research.
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
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their values and how they align with your own. We want you to walk into that interview feeling confident and ready to show them why you’re the perfect fit for the role!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers and get comfortable with common questions. We believe that the more you practice, the more natural and confident you’ll be when it counts.
✨Tip Number 4
Don’t forget to follow up after your interviews! A simple thank-you email can go a long way in leaving a positive impression. We recommend expressing your appreciation for the opportunity and reiterating your enthusiasm for the role.
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 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Executive Director role. Highlight your experience in QA and regulatory compliance, especially in clinical pharmacology. We want to see how your skills align with our needs!
Showcase Your Leadership Skills:This role is all about executive leadership, so don’t hold back! Share examples of how you've led teams and driven quality culture in previous positions. We love to see strong leadership in action!
Be Clear and Concise:When writing your application, keep it straightforward. Use clear language and avoid jargon where possible. We appreciate a well-structured application that gets straight to the point!
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way to ensure your application gets seen by the right people. Plus, it’s super easy to do!
How to prepare for a job interview at Fortrea
✨Know Your Quality Assurance Fundamentals
Make sure you brush up on your knowledge of GCP and GMP regulations. Being able to discuss how these apply to clinical pharmacology and early-phase trials will show that you’re not just familiar with the basics, but that you can also lead a QA strategy effectively.
✨Demonstrate Leadership Experience
Prepare examples from your past roles where you’ve successfully led QA teams or influenced stakeholders. Highlighting your experience in managing global, matrixed teams will resonate well with the interviewers, as they’re looking for someone who can drive quality culture across the organisation.
✨Showcase Your Risk Management Skills
Be ready to discuss how you’ve implemented risk-based quality oversight in previous positions. Share specific instances where you identified risks and the proactive measures you took to mitigate them, especially in early-phase trials.
✨Engage with the Company’s Vision
Research Fortrea’s business strategy and be prepared to discuss how your vision aligns with theirs. Showing that you understand their goals and can contribute to their quality objectives will set you apart as a candidate who is genuinely interested in the role.
