GLP/GCP Lead Internal Auditor | Regulatory Excellence

CLS Labcorp Central Laboratory Services Limited Partnership; Indianapolis (IN); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Life insurance

STD/LTD

401(k)

PTO/FTO

Tuition Reimbursement

Employee Stock Purchase Plan

Job summary

Labcorp is seeking a GLP/GCP Lead Internal Auditor in Indianapolis to oversee, plan and execute the internal audit program across clinical laboratory testing and operations. The role requires coordinating with QA and cross-functional teams to uphold regulatory integrity and drive continuous improvement.

Ideal candidates will have strong leadership, audit strategy experience, and a track record of mentoring auditors while ensuring CAPAs are implemented effectively.

Qualifications

• Bachelor's degree in Pharmacy, Chemistry or Biology.
• MSG or equivalent postgraduate degree; 10+ years experience may substitute.
• 8 years in regulatory environment (GLP/GCP).
• 4 years Laboratory/Quality background ISO 15189/ISO 13485.

Responsibilities

• 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.
• Ensure stakeholder engagement and effective planning across audits.
• Serve as the primary host for internal audits and provide regulatory inspection support.
• Document audit findings and prepare detailed reports with actionable CAPAs.
• Lead monthly audit meetings and monitor activities for regulatory readiness.
• Train and mentor internal auditors; support continual professional development.

Skills

Communication skills

Organizational skills

Project management

Negotiation & networking

Auditing training experience

Quality management systems

Regulatory inspections experience

Process improvement

Education

Bachelor's degree in Pharmacy/ Chemistry/ Biology

MSG or equivalent postgraduate degree

10 years’ experience may substitute for education

8 years in regulatory environment (GLP/GCP)

4 years Laboratory/Quality ISO 15189/ISO 13485

Tools

Veeva Trackwise

Job description

Labcorp is seeking a GLP/GCP Lead Internal Auditor in Indianapolis to oversee, plan and execute the internal audit program across clinical laboratory testing and operations. The role requires coordinating with QA and cross-functional teams to uphold regulatory integrity and drive continuous improvement.

Ideal candidates will have strong leadership, audit strategy experience, and a track record of mentoring auditors while ensuring CAPAs are implemented effectively.