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 compliance software such as Veeva or Trackwise.

Benefits: Employees regularly 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. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here