GLP/GCP Quality Compliance Auditor (Lead Compliance Auditor)
Company: Labcorp
Location: Indianapolis, Indiana, USA
Job ID: 2533058
Category: Regulatory / Compliance
Job Type: Full-Time
Work Schedule: Monday – Friday, 8:00 AM – 5:00 PM
Remote: No
Role Overview
The Lead Compliance Auditor is responsible for leading internal audit programs and ensuring compliance with global regulatory standards across clinical research and laboratory operations. The role focuses on GCP, GLP, ISO 15189, and ISO 13485 compliance, audit execution, inspection readiness, CAPA management, auditor development, and continuous quality improvement initiatives.
This is a senior-level quality assurance and regulatory compliance position requiring strong leadership, auditing expertise, and cross-functional collaboration.
Key Responsibilities
Internal Audit Program Management
Plan, develop, and implement the internal audit program.
Schedule and oversee approved audit activities.
Define and clarify audit scope and objectives.
Assign audits to qualified auditors and monitor execution.
Ensure comprehensive assessment of compliance systems and processes.
Audit Planning & Stakeholder Engagement
Coordinate audit preparation activities.
Ensure engagement of relevant stakeholders throughout the audit lifecycle.
Facilitate effective communication between QA, operations, and management teams.
Maintain transparency and audit readiness across departments.
Audit Execution & Inspection Support
Serve as the primary host for internal audits.
Support regulatory inspections and sponsor audits.
Provide guidance during audit and inspection activities.
Ensure compliance with applicable regulatory requirements and quality standards.
Audit Findings & CAPA Management
Document audit observations and compliance findings.
Prepare detailed audit reports with risk assessments and recommendations.
Collaborate with stakeholders to develop:
Corrective Actions (CA)
Preventive Actions (PA)
Monitor CAPA implementation and effectiveness.
Lead audit review meetings with management.
Compliance Monitoring & Audit Oversight
Lead monthly audit review meetings.
Monitor audit metrics and compliance trends.
Ensure ongoing inspection readiness.
Support alignment with global QA programs and corporate quality systems.
Auditor Training & Development
Train and mentor junior auditors.
Support auditor qualification and competency development.
Collaborate with Regulatory Intelligence teams on emerging regulatory requirements.
Ensure regulatory updates are incorporated into procedures and training programs.
Quality Assurance Support
Participate in strategic QA initiatives.
Support process improvement and compliance enhancement projects.
Contribute to continuous improvement of quality systems and audit processes.
Regulatory & Quality Frameworks
Core Regulatory Standards
Good Laboratory Practice (GLP)
Good Clinical Practice (GCP)
Quality Management Systems
ISO 15189
ISO 13485
Quality Processes
Internal Audits
CAPA Management
Inspection Readiness
Regulatory Compliance
Risk Assessment
Quality Management Systems (QMS)
Minimum Qualifications
Education
Bachelor's Degree in:
Pharmacy
Chemistry
Biology
Related Scientific Discipline
OR
Equivalent experience (10 years may substitute for education requirements).
Experience
8+ years in a regulated environment.
Experience working within:
GLP environments
GCP environments
4+ years in:
Laboratory Quality
Quality Assurance
Compliance functions
Hands-on experience with:
ISO 15189
ISO 13485
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