Insight Global
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. 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)
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.
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 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)
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.