Compliance Lead

Role Overview

• We are seeking a highly structured and experienced Compliance Lead to join our team in Chicago. This role is pivotal in managing GxP regulatory inspections, customer audits, and internal quality assessments. The successful candidate will act as a strategic liaison between system SMEs and audit bodies, ensuring all evidence is precise, timely, and aligned with rigorous SLC (Software Lifecycle) standards.
• Beyond execution, this lead will drive the evolution of our audit support infrastructure by leveraging data analytics to identify gaps, streamline data collection via Smartsheet, and enhance inspection readiness through proactive mock audits.

Key Responsibilities

• Audit Facilitation & Coordination: Lead the audit request process for GxP regulatory inspections and internal quality audits. Partner with system SMEs to ensure evidence fulfills requests within established SLAs.
• Process Improvement: Identify and implement enhancements to the audit support framework. This includes streamlining data collection and optimizing the self-service portal to increase evidence reusability.
• Inspection Readiness: Execute mock audit activities to ensure the organization remains in a constant state of readiness for external inspections.
• Data Analytics & Insights: Build and maintain sophisticated data models to analyze internal observations and external regulatory trends (e.g., Redica, Warning Letters).
• Remediation & Strategy: Propose and execute Continuous Improvement (CI) initiatives based on data-driven insights to proactively address potential compliance gaps.

Required Qualifications

• Experience: 8 years of dedicated experience in compliance, quality assurance, or regulatory affairs within a GxP environment.
• Technical Proficiency: Advanced capability in building data analytics and performing complex analysis on audit data. Experience with Smartsheet for process optimization is highly preferred.
• Expertise: Deep understanding of SLC (Software Lifecycle) and system evidence requirements.
• Communication: Proven ability to engage with C-suite stakeholders and system SMEs with precision and professional diplomacy.

Primary Skill Sets

• GxP Audit Management: Expert-level facilitation of regulatory inspections, customer audits, and internal quality audits.
• Inspection Readiness: Proven track record in executing mock audits and maintaining high-standard regulatory posture.
• Audit Data Analytics: Ability to synthesize complex audit data and external regulatory insights into actionable remediation strategies.