Parexel International Corporation
Senior Project Quality & Risk Lead
Parexel International Corporation, King Of Prussia, Pennsylvania, United States, 19406
*Candidates who have experience as a Clinical Operations Lead/Leader, with QI/Audit/Inspection management experience or equivalent role/responsibilities.
Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. *Candidates with Clinical Trial QC/QA experience from CRO or Pharma. *May consider offering a higher title (Principal) based on experience and ability for the role. The Senior Project Quality and Risk Lead assumes the lead of Quality oversight responsibility and has overall accountability for the execution of the Project Quality Life Cycle Plan (PQLC) within the projects. The PQLC model delivers the services of PQRLs who provide expert quality advice to the project team regarding potential risks and the oversight of risks throughout the lifecycle of the clinical trial. 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, enabling the safeguarding and maintenance of patient safety, data integrity, and regulatory compliance. The Senior Project Quality and Risk Lead acts as Risk Manager, responsible for coordinating Critical to Quality (CtQ) identification, risk evaluation, and controls. This position can also be part of a global project management team. Senior Project Quality and Risk Leads assigned to projects and/or accounts will collaborate closely with broader PQRM groups and other quality teams. Key Accountabilities: Client Liaison Effectively communicate with internal and external customers as well as third-party vendors. Prioritize effectively and respond to urgent quality requests within the team or from sponsors. Serve as the point-of-contact for client quality representatives for projects or accounts. 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 from subject-matter experts. Provide real-time quality expertise to enable project teams to deliver first-time quality. Consult SMEs including other quality experts when necessary to resolve issues. Independently review and investigate possible project-level SOP deviations as requested by project teams. Partner with project teams to achieve and maintain an inspection-ready state, including storyboard oversight. Provide guidance on maintaining inspection-ready documentation for assigned projects. Review/update storyboards for assigned projects as part of inspection preparation, where applicable. Encourage project teams to use storyboards to record pre-developed responses to situations not explained through the TMF. Review storyboards periodically for completeness to ensure inspection-readiness. Proactively identify gaps in documentation, encouraging project teams to document via project-level storyboards where applicable. Develop and cultivate transparent quality relationships, managing expectations with client quality representatives, including fulfilling the role of Portfolio Quality Lead (PFQL) when needed. Lead quality-to-quality meetings as needed. Perform client-level risk and issue management as Portfolio Quality Lead. Provide client-level quality oversight, serving as a point of escalation and communicating pertinent information to account leadership. Develop/revise quality agreements as necessary. Define metrics for reporting quality performance against plans. Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes and participating in process improvement initiatives. Identify scope changes and liaise with Project Leaders. Provide feedback on gaps or issues with Parexel processes. Propose ideas related to departmental efficiencies, improvements, or innovations to PQRM leadership. Review and provide feedback on quality SOPs as assigned. Maintain compliance with Parexel standards. Complete required training curricula. Accurately complete timesheets. Submit expense reports as per SOP. Update CVs as required by SOP. Comply with Parexel processes, ICH-GCPs, and other applicable requirements. Mentor PQRLs and EP Quality Specialists as needed. Facilitate induction to PQRM. Establish formal, documented plans for each new hire. Lead, facilitate, and support risk management processes for assigned projects, partnerships, or accounts using available tools. Lead project-level risk management, working with operational teams, functional leads, and SMEs to identify, categorize, score, and develop mitigations. Ensure mitigations are integrated into project plans and assess their effectiveness. Encourage documenting lessons learned. Lead and facilitate the identification, investigation, and remediation of quality issues, providing oversight and tracking of issues for assigned studies. Triage quality issues in eQMS. Participate in initial assessments of Serious Breach of GCP. Assist in developing containment actions. Facilitate root cause investigations and develop CAPA. Support CAPA effectiveness assessments. Serve as eQMS SME. Analyze risk indicators and investigate signals by performing evaluations and reporting using dashboards, reports, and metrics. Identify risk signals via dashboards. Investigate signals and communicate findings. Identify root causes and develop mitigation plans. Assess mitigation effectiveness. Serve as SME for Risk Signal Evaluations. Assist with audit/inspection preparations, conduct, and response/action plan development. Support audit/inspection prep and review key documents. Provide onsite or remote support, presenting Parexel Quality and QMS overview when needed. Host audits remotely or onsite. Lead root cause investigations and CAPA development. Review audit/inspection responses prior to final QA review if necessary. Serve as eQMS SME. Skills: Excellent interpersonal, verbal, and written communication skills. Strong analytical skills for issue identification and root cause analysis. Ability to develop professional relationships internally and with clients. Good data interpretation and trend analysis skills. Adaptability to changing environments and ambiguity. Strong organizational and workload management skills. Attention to detail, ownership, and accountability. Ability to work effectively in a matrix environment and travel 10-15%.
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Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below. *Candidates with Clinical Trial QC/QA experience from CRO or Pharma. *May consider offering a higher title (Principal) based on experience and ability for the role. The Senior Project Quality and Risk Lead assumes the lead of Quality oversight responsibility and has overall accountability for the execution of the Project Quality Life Cycle Plan (PQLC) within the projects. The PQLC model delivers the services of PQRLs who provide expert quality advice to the project team regarding potential risks and the oversight of risks throughout the lifecycle of the clinical trial. 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, enabling the safeguarding and maintenance of patient safety, data integrity, and regulatory compliance. The Senior Project Quality and Risk Lead acts as Risk Manager, responsible for coordinating Critical to Quality (CtQ) identification, risk evaluation, and controls. This position can also be part of a global project management team. Senior Project Quality and Risk Leads assigned to projects and/or accounts will collaborate closely with broader PQRM groups and other quality teams. Key Accountabilities: Client Liaison Effectively communicate with internal and external customers as well as third-party vendors. Prioritize effectively and respond to urgent quality requests within the team or from sponsors. Serve as the point-of-contact for client quality representatives for projects or accounts. 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 from subject-matter experts. Provide real-time quality expertise to enable project teams to deliver first-time quality. Consult SMEs including other quality experts when necessary to resolve issues. Independently review and investigate possible project-level SOP deviations as requested by project teams. Partner with project teams to achieve and maintain an inspection-ready state, including storyboard oversight. Provide guidance on maintaining inspection-ready documentation for assigned projects. Review/update storyboards for assigned projects as part of inspection preparation, where applicable. Encourage project teams to use storyboards to record pre-developed responses to situations not explained through the TMF. Review storyboards periodically for completeness to ensure inspection-readiness. Proactively identify gaps in documentation, encouraging project teams to document via project-level storyboards where applicable. Develop and cultivate transparent quality relationships, managing expectations with client quality representatives, including fulfilling the role of Portfolio Quality Lead (PFQL) when needed. Lead quality-to-quality meetings as needed. Perform client-level risk and issue management as Portfolio Quality Lead. Provide client-level quality oversight, serving as a point of escalation and communicating pertinent information to account leadership. Develop/revise quality agreements as necessary. Define metrics for reporting quality performance against plans. Identify areas for continuous improvement of the Quality Management System by submitting feedback on processes and participating in process improvement initiatives. Identify scope changes and liaise with Project Leaders. Provide feedback on gaps or issues with Parexel processes. Propose ideas related to departmental efficiencies, improvements, or innovations to PQRM leadership. Review and provide feedback on quality SOPs as assigned. Maintain compliance with Parexel standards. Complete required training curricula. Accurately complete timesheets. Submit expense reports as per SOP. Update CVs as required by SOP. Comply with Parexel processes, ICH-GCPs, and other applicable requirements. Mentor PQRLs and EP Quality Specialists as needed. Facilitate induction to PQRM. Establish formal, documented plans for each new hire. Lead, facilitate, and support risk management processes for assigned projects, partnerships, or accounts using available tools. Lead project-level risk management, working with operational teams, functional leads, and SMEs to identify, categorize, score, and develop mitigations. Ensure mitigations are integrated into project plans and assess their effectiveness. Encourage documenting lessons learned. Lead and facilitate the identification, investigation, and remediation of quality issues, providing oversight and tracking of issues for assigned studies. Triage quality issues in eQMS. Participate in initial assessments of Serious Breach of GCP. Assist in developing containment actions. Facilitate root cause investigations and develop CAPA. Support CAPA effectiveness assessments. Serve as eQMS SME. Analyze risk indicators and investigate signals by performing evaluations and reporting using dashboards, reports, and metrics. Identify risk signals via dashboards. Investigate signals and communicate findings. Identify root causes and develop mitigation plans. Assess mitigation effectiveness. Serve as SME for Risk Signal Evaluations. Assist with audit/inspection preparations, conduct, and response/action plan development. Support audit/inspection prep and review key documents. Provide onsite or remote support, presenting Parexel Quality and QMS overview when needed. Host audits remotely or onsite. Lead root cause investigations and CAPA development. Review audit/inspection responses prior to final QA review if necessary. Serve as eQMS SME. Skills: Excellent interpersonal, verbal, and written communication skills. Strong analytical skills for issue identification and root cause analysis. Ability to develop professional relationships internally and with clients. Good data interpretation and trend analysis skills. Adaptability to changing environments and ambiguity. Strong organizational and workload management skills. Attention to detail, ownership, and accountability. Ability to work effectively in a matrix environment and travel 10-15%.
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