Compliance Lead – GxP
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Job Location:
Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking an experienced Compliance Lead with strong GxP expertise to support audit readiness regulatory inspections and continuous improvement initiatives.
Top Skills Required
Facilitate audit request processes for GxP regulatory inspections & audits
Execute mock audits to ensure inspection readiness
Strong data analytics & audit data analysis experience
Facilitate audit request processes for GxP regulatory inspections & audits
Execute mock audits to ensure inspection readiness
Strong data analytics & audit data analysis experience
Key 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)
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)
Core 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
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
