When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. 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 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. Skills Required: Strong communication and interpersonal skills. E xperience in clinical research ( CAPA management and ICH-GCP standards ) Experience with root cause analysis tools (e.g., 5 Whys, Fishbone). Ability to manage workload independently and in a matrix environment.