GLP/GCP Lead Internal Auditor - Labcorp

Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world’s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you’ll have the opportunity to do meaningful work, grow your career and make a real impact on people’s health around the world. Together, we’re improving health and improving lives.

GLP/GCP Lead Internal Auditor in Indianapolis, IN

Work Schedule: Monday Through Friday 8-5 pm

We are seeking an experienced member to join our Quality Assurance team. The Lead Internal Auditor plays a pivotal role in ensuring that clinical research laboratory testing operations comply with global regulatory standards and industry-recognized best practices, including GCP/GLP, ISO 15189, ISO 13485 and CAP. This position leads the internal audit program execution, drives process improvements, collaborates with management to implement audit strategies, mentors’ junior auditors, and collaborates with cross-functional teams to uphold quality and regulatory integrity across clinical laboratory testing and operational environments. The ideal candidate will possess strong leadership skills, a keen eye for detail, and the ability to oversee complex audit functions in a fast-paced environment with minimal direction. This role requires proactive, timely and responsive engagement with stakeholders, ensuring compliance with industry regulations and internal standards while continuously improving auditing processes.

Job Responsibilities:

Managing the Internal Audit Program:

• Plan and implement the internal audit program.
• Schedule and oversee the approved audit program.
• Develop and clarify audit scopes to ensure comprehensive assessments.
• Approve and assign internal audits to appropriate team members.

Preparedness and Oversight:

• Ensure appropriate stakeholder engagement throughout the audit process.
• Facilitate effective planning and communication with all relevant parties.

Audit Hosting & Regulatory Support:

• Serve as the primary host for internal audits.
• Provide regulatory inspection support and host sponsor audits as required.

Severity Finding and Audit Report Review with Management:

• Document audit findings and develop detailed reports with actionable recommendations.