Sr Project Quality & Risk Lead
Glendale, CA 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 stateProvide 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 toolsFacilitate and support the risk management process for assigned projects using the available toolsFacilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologiesProvide oversight, transparency and tracking of quality issues for assigned studiesAssist with preparations, conduct and response/action plan development for audits/inspections as assignedProvide 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 expertsPartner with project teams to achieve and maintain inspection-ready state including story board oversightDevelop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality LeadIdentify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requestedMaintain compliance with Parexel standardsMentor PQRLs and EP Quality Specialist as neededVery good 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 actionsVery good 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 focusAdvanced ability to manage the complexity of a matrix environment while valuing the importance of teamworkSkills:
Excellent 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 High ability to develop professional, collaborative relationships both internally and with the client Strong 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 Ability to travel 10% - 15% Knowledge and
Experience:
6
years' experience in clinical research Expertise in root cause methodologies (5-whys, fishbone diagram, etc.
) and CAPA development Expertise with ICH-GCP principles English proficiency (written and oral) Education:
Bachelor's Degree or other relevant experience requiredLife-science or other health-related discipline preferred? Master's Degree in a science, technology or industry-related disciple preferred.
This employer is a corporate member ofmyGwork - LGBTQ
professionals, the business community for LGBTQ
professionals,students, inclusive employers & anyone who believes in workplace equality.
Recommended Skills Active Listening Adaptability Analytical Auditing Biology Business Process Improvement Estimated Salary: $20 to $28 per hour based on qualifications.
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 toolsFacilitate and support the risk management process for assigned projects using the available toolsFacilitate identification, investigation and remediation of quality issues as assigned using available tools and methodologiesProvide oversight, transparency and tracking of quality issues for assigned studiesAssist with preparations, conduct and response/action plan development for audits/inspections as assignedProvide 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 expertsPartner with project teams to achieve and maintain inspection-ready state including story board oversightDevelop and cultivate transparent quality relationships, while managing expectations with client quality representatives, including when needed fulfilling the role of Portfolio Quality LeadIdentify areas for continuous improvement of the Quality Management System by submitting feedback on processes, participating in process improvement initiatives as requestedMaintain compliance with Parexel standardsMentor PQRLs and EP Quality Specialist as neededVery good 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 actionsVery good 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 focusAdvanced ability to manage the complexity of a matrix environment while valuing the importance of teamworkSkills:
Excellent 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 High ability to develop professional, collaborative relationships both internally and with the client Strong 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 Ability to travel 10% - 15% Knowledge and
Experience:
6
years' experience in clinical research Expertise in root cause methodologies (5-whys, fishbone diagram, etc.
) and CAPA development Expertise with ICH-GCP principles English proficiency (written and oral) Education:
Bachelor's Degree or other relevant experience requiredLife-science or other health-related discipline preferred? Master's Degree in a science, technology or industry-related disciple preferred.
This employer is a corporate member ofmyGwork - LGBTQ
professionals, the business community for LGBTQ
professionals,students, inclusive employers & anyone who believes in workplace equality.
Recommended Skills Active Listening Adaptability Analytical Auditing Biology Business Process Improvement Estimated Salary: $20 to $28 per hour based on qualifications.
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