Compliance Analyst III

Job Summary

We are seeking a highly skilled, experienced Senior QA Compliance Auditor to join our team on a contract-to-hire basis. This role supports clinical research drug development, offering commercial diagnostic laboratory testing services within a highly regulated setting. The ideal candidate will bring deep expertise with an action-oriented mindset and the ability to lead challenging audit activities across the global enterprise to ensure operational compliance to GCP, GCLP, ISO , ISO , CAP / CLIA regulations and industry standards.

Key Responsibilities

• Audit Planning, Execution & Oversight

o Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions.

o Host and support sponsor-client audits and regulatory inspections

o Perform external audits of suppliers and service providers.

o Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders.

• Compliance Monitoring & Issue Resolution

o Evaluate adherence to SOPs, regulatory requirements, and industry standards.

o Lead the response process for audits and inspections, including CAPA development, implementation and tracking.

o Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness.

o Support global QA policy implementation and interpretation of regulatory requirements.

o Ensure compliance with applicable regulations (GCP, ISO , CAP, etc.) and internal quality standards.

o Participate in global quality initiatives to improve compliance and operational efficiency.

• Training & Continuous Improvement

o Develop, deliver and participate in training on audit practices and compliance expectations.

o Promote a culture of quality and continuous improvement across teams.

• Documentation & Reporting

o Prepare detailed audit reports with actionable recommendations.

o Track and report quality metrics, identifying trends and areas for improvement.

o Maintain audit records and ensure inspection readiness.

Qualifications

• Education :

o Bachelor’s degree in life sciences or related field; advanced degree preferred.

o Equivalent experience may be considered in lieu of advanced education requirements .

• Experience :

o Minimum years in a regulatory or GxP-compliant environment.

o Proven experience with quality systems and regulatory inspections.

o Strong understanding of ISO , ISO , and risk-based auditing methodologies.

• Skills :

o Strong communication, organizational, negotiation, and problem-solving skills.

o Ability to influence cross-functional teams and drive compliance initiatives.

o Success-oriented in working both independently and in dynamic team environments.

o Proficiency with quality management system applications and / or platforms (, Veeva, TrackWise) is a plus.

• Certifications (Preferred) :

o ASQ Certified Quality Auditor (CQA)

o ASQ Certified Quality Manager or Quality Engineer (CQM / CQE)

o SQA Registered Quality Assurance Professional (RQAP)

Additional Information

• Travel : Occasional regional travel (?%) may be required.
• Work Environment : Onsite role based in Indianapolis, IN.
• Contract Type : Contract-to-hire with potential for full-time conversion based on performance and business needs.

If you are passionate about quality, compliance, and continuous improvement, we encourage you to apply and be part of a team that values excellence and integrity in clinical research.

EEO :