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Glp/gcp quality compliance auditor

United States of America, Indianapolis Employment contract · Job Posted May 04, 2026
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Job Description

We are seeking an experienced member to join our Quality Assurance team. The 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 Responsibility

  • 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

Requirements

  • 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 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
  • Experience with compliance software such as Veeva or Trackwise

Nice to have

  • 8 years - Regulatory expertise - detailed knowledge of specific regulation/ 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

What we offer

  • Medical
  • Dental
  • Vision
  • Life
  • STD/LTD
  • 401(k)
  • Paid Time Off (PTO) or Flexible Time Off (FTO)
  • Tuition Reimbursement
  • Employee Stock Purchase Plan

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