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