GLP​/GCP Quality Compliance Auditor

** 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 specifically with ISO 15189/ISO 13485 standards.

*
* Preferred Qualifications:

*
* + 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

** Additional Job 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 com…