Senior Risk And Compliance Lead (Root Cause Analysis) - Fsp (Mercedes)

Senior Risk And Compliance Lead (Root Cause Analysis) - Fsp (Mercedes)

Overview
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 Quality Events (QEs).
This individual will also support, as necessary, the implementation of assigned plan components and tracking of actions and effectiveness checks to completion.
Job Responsibilities
This individual will be responsible to:




Lead the investigation/root cause analysis and CAPA plan development for assigned cases
Support the implementation of assigned plan components and tracking of actions to completion as necessary
Ensure documentation of root cause analysis and CAPA plan are accurate, complete and inspection ready
Root Cause Analysis / Due Diligence
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 brought in to conduct just the RCA portion of the investigation for systemic issues, process-related issues or business-critical cases.
Training
This individual will also be required to train new Investigation Case Leads in the Root Cause Analysis Methodology and provide mentoring to new Investigation Case Leads while they obtain RCA Certification.
The RCA Specialist will also be a subject matter expert in the sponsor's methodology and will be a resource to case leads to implement PHP in the investigation process and help teams error-proof the process in question.
CAPA Plan Development and Management




Based on identified root causes, the individual will guide the SQE team in identifying appropriate corrective and preventive actions 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.); analyze and optimize current business processes and develop and implement new business processes.
This individual will hold accountability for ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits.
Ensure implementation of QE/audit/inspection CAPAs and remediation plans
Track effectiveness checks and report on trends
Qualifications
BS – 10+ years or equivalent




MS/MBA – 9+ years or equivalent
Previous Experience
Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
Regulatory inspection experience
Process and system management experience
Detailed knowledge of clinical trial processes and relationships required
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
Previous experience in conducting Root Cause Analysis,



Error Proofing/Mistake Proofing and helping analyze trends in data to identify potential investigations to address systemic process issues or program/protocol level issues
This role will involve working with Vendor Quality and Clinical Quality colleagues
Work with Vendor Quality and Clinical Quality groups to assist in developing investigation strategies related to vendor issues and program level quality issues
Experience in leading process improvement efforts from inception to execution
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📌 Senior Risk And Compliance Lead (Root Cause Analysis) - Fsp (Mercedes)
🏢 Parexel
📍 Argentina