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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Project Quality and Risk Lead
Job ID R0000033744 Harrow, England, United KingdomDue to a growing portfolio, we are currently looking for Project Quality and Risk Lead to be based in London with flexible working hours.
This position requires being at the at Clinical Unit (Northwick Park Hospital) initially 1/2 day per week as agreed with Line Manager.
The Project Quality & Risk Lead is responsible for leading quality and risk oversight for clinical trials within the Early Phase Clinical Units.
Reporting into the regional Manager, this role ensures first-time quality, robust risk and issue management and inspection readiness by collaborating with operational teams and clients. Key duties include facilitating risk assessments, managing quality events, supporting audits and inspections, and providing expert guidance on regulatory compliance.
The position requires strong analytical, communication, and problem-solving skills, along with experience in clinical research, quality management, and ICH-GCP standards. It also involves mentoring new team members and contributing to continuous improvement initiatives
Key Responsibilities:
Client Liaison & Communication
- Act as the main contact for client quality representatives.
- Respond to urgent quality requests and facilitate quality-to-quality meetings.
Risk Management
- Lead risk identification and mitigation processes.
- Develop and assess risk mitigation strategies and quality tolerance limits.
Quality Event Management
- Triage and classify quality issues.
- Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).
Inspection Readiness
- Conduct Inspection Readiness Checks (IRCs).
- Support audit/inspection preparation and response.
Quality Consultancy
- Provide real-time quality advice.
- Review SOP deviations and consult with SMEs
Documentation & Storyboards
- Ensure inspection-ready documentation.
- Oversee storyboard development and updates.
Continuous Improvement
- Identify and propose process improvements.
- Participate in quality system enhancements.
Mentorship
- Mentor and train new PQRLs.
Knowledge and Experience:
- Strong communication and interpersonal skills
- Ability to manage workload independently and in a matrix environment.
- Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
- Experience in clinical research ( CAPA management and ICH-GCP standards ) is essential
- Experience with root cause analysis tools (e.g., 5 Whys, Fishbone)
Education:
Bachelor’s Degree or other relevant experience required. Life-science, health or industry-related discipline preferred
In return we will be able to offer you a structured career pathway and encouragement to develop within the role including awareness and understanding of the industry. You will be well supported and for your hard work you will be rewarded with a competitive base salary, bonus as well as a benefits package including holiday, private healthcare, dental insurance as well as other benefits that you would expect with a top company in the CRO Industry.
Apply today to begin your Parexel journey!
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