Mindlance · 13 hours ago
Compliance Analyst III
Indianapolis, IN
Full-time
Onsite
Senior Level
6+ years expMindlance is a company focused on regulatory compliance and quality assurance, seeking a highly skilled Senior QA Compliance Auditor on a contract-to-hire basis. This role supports clinical research drug development and involves leading audit activities to ensure compliance with various regulatory standards.
Human Resources
Responsibilities
Plan, schedule, and conduct audits across the clinical laboratory, and operational support functions
Host and support sponsor-client audits and regulatory inspections
Perform external audits of suppliers and service providers
Support audit response development and CAPA implementation, ensuring responsiveness and delivery requirements are met for client and business stakeholders
Evaluate adherence to SOPs, regulatory requirements, and industry standards
Lead the response process for audits and inspections, including CAPA development, implementation and tracking
Monitor and drive closure of audit-related deliverables, ensuring timely completion and effectiveness
Support global QA policy implementation and interpretation of regulatory requirements
Ensure compliance with applicable regulations (GCP, ISO 15189, CAP, etc.) and internal quality standards
Participate in global quality initiatives to improve compliance and operational efficiency
Develop, deliver and participate in training on audit practices and compliance expectations
Promote a culture of quality and continuous improvement across teams
Prepare detailed audit reports with actionable recommendations
Track and report quality metrics, identifying trends and areas for improvement
Maintain audit records and ensure inspection readiness
Qualification
Required
Bachelor's degree in life sciences or related field; advanced degree preferred
Minimum 6 years in a regulatory or GxP-compliant environment
Proven experience with quality systems and regulatory inspections
Strong understanding of ISO 15189, ISO 13485, and risk-based auditing methodologies
Strong communication, organizational, negotiation, and problem-solving skills
Ability to influence cross-functional teams and drive compliance initiatives
Success-oriented in working both independently and in dynamic team environments
Proficiency with quality management system applications and/or platforms (e.g., Veeva, TrackWise) is a plus
Preferred
ASQ Certified Quality Auditor (CQA)
ASQ Certified Quality Manager or Quality Engineer (CQM/CQE)
SQA Registered Quality Assurance Professional (RQAP)
Company
Mindlance
Mindlance is a Staffing and Recruiting company which provides multi-vertical staffing services
1001-5000 employees
H1B Sponsorship
Mindlance has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (53)
2023 (37)
2022 (72)
2021 (36)
2020 (40)
Funding
Current Stage
Late StageLeadership Team
R
Rajat Paul Dhall
Co-Founder & Managing Director
V
Vik Kalra
Co-Founder and Managing Director
Recent News
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