Senior Project Quality

3 weeks ago

Southeast Fairbanks, United States Parexel Full time

Home Based, US

As a Sr Project Quality & Risk Lead you will partner with operational delivery teams focusing on first-time quality, robust risk and issue management and maintaining an inspection-ready state. Provide quality expertise to support operations, leadership and clients.

Responsibilities:

Analyze key risk indicators and investigate risk signals by performing, reporting and coordinating risk signal evaluations for assigned projects using dashboards, reports, metrics and other available tools.Facilitate and support 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 role of Portfolio 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. Mentor PQRLs and EP Quality Specialist as needed.Very good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.Superior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actions.Very good skills 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.Advanced ability to manage the complexity of a matrix environment while valuing the importance of teamwork.Skills:Excellent interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedbackSuperior analytical skills focusing on identifying potential and real issues, investigating root causes, brainstorming and imagining alternatives and assessing the effectiveness of actionsHigh ability to develop professional, collaborative relationships both internally and with the clientStrong skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issuesAdaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledgeAbility to plan, organize, prioritize and manage workload independently, keeping the patient and client at the focusAbility to travel 10% - 15%Knowledge and Experience:6+ years' experience in clinical researchExpertise in root cause methodologies (5-whys, fishbone diagram, etc.) and CAPA developmentExpertise with ICH-GCP principlesEnglish proficiency (written and oral)Education:Bachelor's Degree or other relevant experience required. Life-science or other health-related discipline preferred.  Master's Degree in a science, technology or industry-related disciple preferred.
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