GLP/GCP Lead Internal Auditor

Labcorp•Indianapolis, IN

4d•Onsite

About The Position

Labcorp is 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.

Requirements

Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline
8 years in regulatory environment (experience in GLP/GCP roles)
4 years Laboratory / Quality background specifically with ISO 15189/ISO 13485 standards.
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.
Experience with quality management system and regulatory compliance inspections
Experience leading process improvement initiatives

Nice To Haves

Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable.
10 years’ experience may be substituted for education.
8 years - Regulatory Industry expertise - GCP/GLP, ISO 15189, ISO 13485 and CAP
2 years’ experience as Lead Internal Auditor with strategic communication with clients
ASQ Quality Auditor Certification
ASQ Quality Manager Certification
ASQ Quality Engineer Certification
Experience with compliance software such as Veeva or Trackwise.

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 appropriate stakeholder engagement throughout the audit process.
Facilitate effective planning and communication with all relevant parties.
Serve as the primary host for internal audits.
Provide regulatory inspection support and host sponsor audits as required.
Document audit findings and develop detailed reports with actionable recommendations.
Collaborate with stakeholders to implement CAPAs and monitor their effectiveness.
Lead audit review meetings and collaborate with management to address compliance gaps.
Lead and manage monthly audit meetings.
Monitor audit activities, ensuring alignment with regulatory requirements.
Ensure audit and regulatory inspection readiness, in harmony with CLS QA programs and global processes
Provide training and mentorship for internal auditors.
Collaborate with QA management and Regulatory Intelligence to ensure regulatory updates are proceduralized and embraced through staff training and team huddles.
Develop audit leads and ensure continuous professional development and compliance awareness.
Support, lead and participate in QA projects as needed to uphold compliance standards and continuous improvement strategic initiatives.