GLP/GCP Quality Compliance Auditor

Lead Compliance Auditor - 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 Bachelor's degree in 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 specifically with ISO 15189/ISO 13485 standards. Preferred Qualifications 8 years of regulatory expertise and detailed knowledge of specific regulation(s) and multiple regulations. 2 years’ experience as Lead Auditor with strategic communication with clients. ASQ Quality Auditor Certification. ASQ Quality Manager Certification. ASQ Quality Engineer Certification. Additional Job Standards Strong written and verbal communication skills. Excellent organizational and project management abilities. Strong negotiation, influencing and networking skills. Experience in risk management application, including risk‑based auditing methodologies. Experience training and developing internal auditors. Experience with quality management system and regulatory compliance inspections. Experience leading process improvement initiatives. Experience with compliance software such as Veeva or Trackwise. Benefits Employees scheduled to work 20 or more hours per week are eligible for comprehensive benefits including Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees scheduled to work less than 20 hours per week are eligible to participate in the 401(k) plan only. Equal Opportunity Employer Statement Labcorp is proud to be an Equal Opportunity Employer. Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. We encourage all to apply. If you have a disability and need assistance using our online tools to search and apply for jobs, or need an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. #J-18808-Ljbffr CLS Labcorp Central Laboratory Services Limited Partnership