GLP/GCP Lead Internal Auditor
On-siteIndianapolis, Indiana, United States
Job Summary
Plan and execute the internal audit program by scheduling audits, defining scopes, and assigning tasks to team members. Serve as the primary host for internal and sponsor audits while ensuring stakeholder engagement throughout the process. Document findings, develop detailed reports with actionable recommendations, and collaborate with management to implement CAPAs and monitor their effectiveness. Lead monthly audit meetings, manage audit activities for regulatory inspection readiness, and mentor junior auditors through training and professional development initiatives. Support QA projects and drive process improvements to uphold compliance with GCP, GLP, ISO 15189, and CAP standards.
Required Qualifications
- 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
Desired Qualifications
- 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
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