Compliance Analyst III

Job Title: Senior QA Compliance Auditor (Contract-to-Hire)
Job Type: Contract-to-Hire
Department: Regulatory Compliance & Quality Assurance

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 13485, ISO 15189, 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.
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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 15189, 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 6 years in a regulatory or GxP-compliant environment.
o Proven experience with quality systems and regulatory inspections.
o Strong understanding of ISO 15189, ISO 13485, 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 (e.g., 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 (?5%) 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:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."