At a Glance
- Tasks: Lead QA and regulatory compliance for clinical pharmacology, ensuring top-notch quality management.
- Company: Fortrea, a leader in clinical pharmacology services with a focus on innovation.
- Benefits: Competitive salary, flexible hours, and opportunities for professional growth.
- Other info: Dynamic work environment with global travel opportunities and career advancement.
- Why this job: Make a real impact in clinical trials and shape the future of healthcare.
- Qualifications: Extensive experience in QA roles, strong knowledge of GCP and GMP standards.
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 QA & Regulatory Lead, Clinical Pharmacology 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, UK, our employees enjoy a collaborative work atmosphere and the chance to make a meaningful impact in clinical research.
StudySmarter Expert Advice🤫
We think this is how you could land Executive QA & Regulatory Lead, Clinical Pharmacology in Leeds
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage 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!
✨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 it will feel when it’s time to shine.
✨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 and reiterating your enthusiasm for the role – it shows you’re genuinely interested!
We think you need these skills to ace Executive QA & Regulatory Lead, Clinical Pharmacology 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 skills align with the specific responsibilities outlined in the job description.
Showcase Your Leadership Skills:Since this role is all about executive leadership, don’t forget to emphasise your past experiences leading teams and driving quality strategies. We love seeing examples of how you've influenced change and improved processes.
Be Clear and Concise:When writing your application, keep it straightforward and to the point. We appreciate clarity, so make sure your key achievements and qualifications stand out without unnecessary fluff.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy!
How to prepare for a job interview at Fortrea
✨Know Your QA and Regulatory Stuff
Make sure you brush up on your knowledge of GCP and GMP regulations, especially as they relate to clinical pharmacology. Be ready to discuss how you've implemented these standards in past roles, as this will show your expertise and readiness for the position.
✨Showcase Your Leadership Skills
Prepare examples that highlight your experience in leading QA teams and managing compliance risks. Think about specific situations where you influenced stakeholders or drove a quality culture within an organisation, as this will demonstrate your executive presence.
✨Be Ready for Scenario Questions
Expect questions that ask how you would handle specific challenges related to inspection readiness or risk management in clinical trials. Practise articulating your thought process and decision-making strategies, as this will showcase your problem-solving skills.
✨Align with the Company’s Vision
Research Fortrea's business strategy and be prepared to discuss how your QA strategy aligns with their objectives. Showing that you understand their goals and can contribute to them will set you apart from other candidates.
