At a Glance
- Tasks: Lead Quality Assurance and Regulatory Compliance for Clinical Pharmacology Services, ensuring top-notch quality management.
- Company: Join 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: Work from various locations including the UK, with travel opportunities.
- Why this job: Make a significant impact on clinical trials and drive quality culture in a dynamic environment.
- Qualifications: 15+ years in clinical trials, strong GCP/GMP expertise, and leadership experience required.
The predicted salary is between 100000 - 150000 £ 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.
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Partner with stakeholders to manage QA budgets supporting CPS.
- Ensure efficient delivery of QA services aligned with quality, cost, and timeline expectations.
- ~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.
- 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 in Leeds employer: Fortrea
Fortrea is an exceptional employer that prioritises a culture of quality, compliance, and operational excellence within its Clinical Pharmacology Services. With a strong commitment to employee growth, we offer robust training and development opportunities, ensuring our team members are equipped to lead in a dynamic regulatory environment. Located in vibrant cities like Leeds, UK, our employees enjoy a collaborative work atmosphere, competitive benefits, and the chance to make a meaningful impact in clinical pharmacology.
StudySmarter Expert Advice🤫
We think this is how you could land Executive Director, Clinical Pharmacology Services Quality Assurance 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 can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their quality assurance strategies and be ready to discuss how your experience aligns with their needs. We want you to shine and show them why you’re the perfect fit!
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your responses and boost your confidence. We believe that being well-prepared can make all the difference when it comes to landing that dream job.
✨Tip Number 4
Don’t forget to follow up after interviews! A simple thank-you email can leave a lasting impression and keep you top of mind. We recommend applying through our website to streamline your application process and stay updated on new opportunities.
We think you need these skills to ace Executive Director, Clinical Pharmacology Services Quality Assurance in Leeds
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in QA and regulatory compliance. We want to see how your background aligns with the specific needs of the Clinical Pharmacology Services role.
Showcase Your Leadership Skills:Since this is an executive position, it's crucial to demonstrate your leadership capabilities. Share examples of how you've led teams and influenced stakeholders in previous roles, especially in clinical trials and quality assurance.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. Use clear language to convey your qualifications and experiences, making it easy for us to see why you’re a great fit for the role.
Apply Through Our Website:We encourage you to submit your application through our website. This ensures that your application goes directly to our recruitment team, making the process smoother for everyone involved.
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, especially as they relate to clinical pharmacology. Being able to discuss these concepts confidently will show that you’re not just familiar with the terms but can apply them in a practical context.
✨Demonstrate Leadership Experience
Prepare specific examples from your past roles where you led QA teams or implemented quality strategies. Highlight how you influenced stakeholders and drove a culture of compliance and operational excellence. This will showcase your executive presence and ability to lead in a matrixed environment.
✨Showcase Your Risk Management Skills
Be ready to discuss how you've developed and executed risk-based quality oversight programs in previous positions. Share insights on how you identified risks and implemented proactive measures, as this aligns closely with the role's focus on continuous improvement and inspection readiness.
✨Engage with the Company’s Vision
Familiarise yourself with Fortrea’s business strategy and how the CPS unit fits into it. During the interview, express your enthusiasm for their mission and how your experience can contribute to their goals. This will demonstrate your genuine interest in the role and the company.
