GLP​/GCP Lead Quality Auditor

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.

** Lead Compliance 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 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.

*
* 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.

+ Collaborate with stakeholders to implement CAPAs and monitor their effectiveness.

+ Lead audit review meetings and collaborate with management to address compliance gaps.

** Audit Program Monitoring:*
* +  
** 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

** Internal Auditor Development:*
* + 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.

** Quality Assurance (QA) Support:*
* +  
** Support, lead and participate in QA projects
** as needed to uphold compliance standards and continuous improvement strategic initiatives.

** Minimum Qualifications

Required:

*
* + Bachelor's degree in a Pharmacy, Chemistry or Biology related discipline Postgraduate degree (MSG or equivalent) in science or management related discipline, preferable. 10 years' experience may be substituted for education.

+ 8 years in regulatory environment (experience in GLP/GCP roles)

+ 4 years Laboratory / Quality background…