Senior Lead Compliance Auditor

Senior Lead Compliance Auditor

If you have a passion for compliance auditing and a drive for operational excellence, join our growing Quality team as a Senior Lead Compliance Auditor and take your career to the next level at Labcorp.

This is an Onsite position at 8211 Scicor Drive, Indianapolis, IN.

Imagine being involved in innovation and projects that change the course of our industry daily! At Labcorp, one of the world's largest and most comprehensive pharmaceutical solutions service companies, you will have an opportunity to build an exciting career while you make a direct impact on the lives of millions.

Job Summary

We are seeking an experienced member to join our Quality Assurance team. The Senior Lead Compliance 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, and ISO 13485. 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.

Essential Functions

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 :

Audit Hosting & Regulatory Support :

Severity Finding and Audit Report Review with Management :

Audit Program Monitoring :

Internal Auditor Development :

Quality Assurance (QA) Support :

Preferred Skills & Qualifications

Strong written and verbal communication skills.

Excellent organizational and project management abilities.

Strong negotiation, influencing, and networking skills.

Demonstrative skills include risk management application experience including risk-based auditing methodologies.

Experience in training and developing internal auditors.

Laboratory / Quality background specifically with ISO 15189 / ISO 13485 standards.

Experience with quality management system and regulatory compliance inspections.

Experience with compliance software such as Veeva or Trackwise.

Recommended Certifications

If you have a passion for compliance auditing and a drive for operational excellence, we invite you to apply for this exciting opportunity.

Education / Experience Requirements

Minimum of a Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable. Experience may be substituted for education.

Minimum of 8 years in regulatory environment (experience in GXP roles)