Senior Risk and Compliance Lead (Root Cause Analysis) - FSP

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 individualwillberesponsible 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