Senior Risk and Compliance Lead (Root Cause Analysis) - FSP
# Senior Risk and Compliance Lead (Root Cause Analysis) - FSP **Parexel** · Brazil · `Remote` · `Full Time` 💼 **Уровень роли:** `Senior` 🕒 **Статус:** *Опубликовано: сегодня* · *Источник: Himalayas (JSON API)* --- ### Top Skills & Match 🎯 **Ключевой стек роли:** `[Risk-And-Compliance]` `[Quality-Assurance]` `[Clinical-Quality-Assurance]` `[Root-Cause-Analysis]` `[CAPA-Management]` `[Regulatory-Compliance]` `[Principal-Risk-And-Compliance-Analyst]` `[Senior-Governance-Risk-And-Compliance-Specialist]` `[Risk-Management-Lead]` `[Senior-Risk-Management-Specialist]` --- ### About the Role 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. Parexel is seeking a Senior Risk and Compliance Lead (Root Cause Analysis) to join our team! Candidates can be based anywhere in Brazil, Mexico or Argentina ! Job Summary The Senior Risk and Compliance Lead (Root Cause Analysis) will be accountable to train Sr / Issue Leads on the investigation/root cause analysis, corrective/preventive action (CAPA) plan development and effectiveness checks for assigned QualityEvents(QEs).Thisindividualwillalsosupport,asnecessary, the implementation of assigned plan components and tracking of actions and effectiveness checks to completion. Job Responsibilities This individual willberesponsible to: - Lead the investigation/root cause analysis, corrective/preventiveaction(CAPA)plandevelopmentfor assigned cases - Supportimplementationofassignedplancomponentsand tracking of actions to completion as necessary - EnsuredocumentationofrootcauseanalysisandCAPA plan are accurate, complete and inspection ready RootCauseAnalysis/DueDiligence This individual will also be required to apply a root cause methodology and/or due diligence approach to the case. This individual may either lead QE cases from start to finish or be broughtinconductjusttheRCAportionoftheinvestigationfor systemicissues,processrelatedissueorbusinesscriticalcases. Training ThisindividualwillalsoberequiredtotrainnewInvestigationCase Leads in the Root Cause Analysis Methodology and provide mentoring to new Investigation Case Leads while they obtain RCA Certification. TheRCASpecialistwillalsobeasubjectmatterexpertin the sponsor's methodologyandwillbearesourceto caseleadstoimplementPHPintheinvestigationprocessandhelp teams error proof the process in question. CAPAPlanDevelopmentandManagement Based on identified root causes, the individual will guide the SQE teaminidentifyingappropriatecorrectiveandpreventiveactions and conducting effectiveness checks on implemented actions to ensure they are working as expected. Leverage process improvement best practice techniques (i.e., Six Sigma,Lean,etc.);analyzeandoptimizecurrentbusinessprocesses and develop and implement new business processes. Thisindividualwillholdaccountabilityforongoingmonitoringof CAPAcompletionandtrackingofeffectivenessforimplemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits - EnsureimplementationofQE/audit/inspectionCAPAsand remediation plans - Trackeffectivenesschecksandreportontrends. Qualifications BS – 10+ years or equivalent MS/MBA–9+yearsorequivalent PreviousExperience: - Minimum of 5 years of pharmaceutical experience with solidexperienceindatamanagement,operationalaspects, GCP Quality, GxP Quality, and/or regulatory - Regulatoryinspectionexperience - Processandsystemmanagementexperience - Detailedknowledgeofclinicaltrialprocessesand relationships required - KnowledgeofGCPrequirementsandapplicableSOPsand regulations - Project management, administrative, and technical capabilitiesarerequired,aswellaseffectiveverbaland writtencommunicationskills - Strongbackgroundincontinuousimprovement methodology (i.e., Lean Six Sigma) preferred - Previous Experience in conducting Root Cause Analysis, Error Proofing/Mistake Proofing andhelpanalyzetrendsindata to identify potential investigations to address systemic process issues or program/protocol level issues. - ThisrolewillinvolveworkingwithVendorQualityand Clinical Quality colleagues. - WorkwithVendorQualityandClinicalQualitygroupsto assist in developing investigation strategies related to vendor issues and program level quality issues. - Experienceinleadingprocessimprovementeffortsfrom inception to execution Originally posted on Himalayas
- Risk-And-Compliance
- Quality-Assurance
- Clinical-Quality-Assurance
- Root-Cause-Analysis
- CAPA-Management
- Regulatory-Compliance
- Principal-Risk-And-Compliance-Analyst
- Senior-Governance-Risk-And-Compliance-Specialist
- Risk-Management-Lead
- Senior-Risk-Management-Specialist
Наблюдалась 2026-10-03, впервые 2026-10-02, источник — Himalayas (JSON API).