Lead Internal Auditor - GLP/GCP & Quality Assurance

Labcorp; Indianapolis (IN); On-site; USD 95,000 - 135,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) & ESPP

Job summary

Labcorp is seeking a GLP/GCP Lead Internal Auditor to join our Indianapolis Quality Assurance team. This role drives the internal audit program to ensure compliance with global standards including GCP/GLP, ISO 15189, ISO 13485 and CAP, while mentoring junior auditors and coordinating with cross-functional teams.

The ideal candidate will lead audits, manage CAPAs, support regulatory inspections, and oversee audit reporting in a fast-paced laboratory environment, aligning with CLS QA programs and

Qualifications

• Bachelor's degree in Pharmacy, Chemistry or Biology related discipline; MSG or equivalent preferred; 10 years’ experience may substitute for education.
• 8 years in regulatory environment (GLP/GCP roles).
• 4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards.

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.
• Prepare stakeholder engagement throughout the audit process.
• Facilitate effective planning and communication with all relevant parties.
• Serve as the primary host for internal audits and provide regulatory inspection support.
• Lead audit review meetings and implement CAPAs with management.

Skills

Regulatory (GLP/GCP)

Audit leadership

Stakeholder management

Quality assurance

Education

Bachelor's degree in Pharmacy/Chemistry/Biology

Postgraduate degree in science or management

Tools

Veeva

TrackWise

Job description

Labcorp is seeking a GLP/GCP Lead Internal Auditor to join our Indianapolis Quality Assurance team. This role drives the internal audit program to ensure compliance with global standards including GCP/GLP, ISO 15189, ISO 13485 and CAP, while mentoring junior auditors and coordinating with cross-functional teams.

The ideal candidate will lead audits, manage CAPAs, support regulatory inspections, and oversee audit reporting in a fast-paced laboratory environment, aligning with CLS QA programs and