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Job Description
Due 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
1. Act as the main contact for client quality representatives.
2. Respond to urgent quality requests and facilitate quality-to-quality meetings.
Risk Management
3. Lead risk identification and mitigation processes.
4. Develop and assess risk mitigation strategies and quality tolerance limits.
Quality Event Management
5. Triage and classify quality issues.
6. Facilitate root cause analysis (RCA) and corrective/preventive actions (CAPA).
Inspection Readiness
7. Conduct Inspection Readiness Checks (IRCs).
8. Support audit/inspection preparation and response.
Quality Consultancy
9. Provide real-time quality advice.
10. Review SOP deviations and consult with SMEs
Documentation & Storyboards
11. Ensure inspection-ready documentation.
12. Oversee storyboard development and updates.
Continuous Improvement
13. Identify and propose process improvements.
14. Participate in quality system enhancements.
Mentorship
15. Mentor and train new PQRLs.
Knowledge and Experience:
16. Strong communication and interpersonal skills
17. Ability to manage workload independently and in a matrix environment.
18. 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
19. Experience in clinical research ( CAPA management and ICH-GCP standards ) is essential
20. Experience with root cause analysis tools (e.g., 5 Whys, Fishbone)
Education:
21. 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.
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