Project Quality and Risk Lead II (flexible location)

We are now looking for a Project Quality Lead II. In this role, you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. You will also provide quality expertise through the execution of quality SOPs to support operations, leadership and clients.

Key Accountabilities: Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk-based quality evaluations for assigned projects using dashboards, reports, metrics and other available tools. Facilitate and drive the risk management process for assigned projects using the available tools. Facilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologies. Provide oversight, transparency and tracking of quality issues for assigned studies. Assist with preparations, conduct and response/action plan development for audits/inspections as assigned. Provide expert quality advice as assigned, responding to consultancy requests and requests for SOP deviations using ICH-GCP, Parexel processes, regulatory requirements, applicable country requirements and input of appropriate subject-matter experts. Partner with project teams to achieve and maintain inspection-ready state including story board oversight. Develop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the roles of Portfolio/Client Quality Lead. Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requested Maintain compliance with Parexel standards. QualificationsSkills and Experience required for the role: Bachelor’s Degree or other relevant experience required. Life-science or other health-related discipline preferred. 5 years’ experience in late phase clinical research Experience using root cause methodologies (5-whys, fishbone diagram, etc.) Knowledge of ICH-GCP principles Analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions. Ability to develop professional, collaborative relationships both internally and with the client. Skilled in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge. Ability to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focus. Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables. English proficiency (written and oral)