Compliance Lead – GxP

TekCommands • Chicago, IL

1d

About The Position

We are seeking an experienced Compliance Lead with strong GxP expertise to support audit readiness, regulatory inspections, and continuous improvement initiatives.

Requirements

• Strong experience in GxP compliance and regulatory audits
• Proven ability to manage audit processes end-to-end
• Experience with data analysis and reporting in compliance environments
• Excellent stakeholder communication and coordination skills

Nice To Haves

• Facilitate audit request processes for GxP regulatory inspections & audits
• Execute mock audits to ensure inspection readiness
• Strong data analytics & audit data analysis experience

Responsibilities

• Lead audit request support for regulatory inspections, customer audits, and internal quality audits
• Coordinate with SMEs to gather audit evidence and ensure timely responses aligned with SLAs
• Drive process improvements to streamline audit data collection and enhance efficiency
• Improve and promote self-service audit portals and evidence reuse strategies
• Conduct mock audits to strengthen inspection readiness
• Analyze audit data including internal audits, external inspections, and observations
• Identify gaps, risks, and remediation opportunities
• Develop insights and present recommendations for continuous improvement initiatives
• Leverage tools and platforms for analytics and reporting (e.g., Smartsheet or similar)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed