Senior Risk and Compliance Lead

Job Description

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

The Senior Risk and Compliance Lead (Root Cause Analysis) will be responsible to:

• Lead the investigation/root cause analysis, corrective/preventive action (CAPA) plan development for assigned cases.
• Support 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 expectedfor 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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