Compliance Lead at Themesoft in Chicago, IL – Contract 2026

Job ID: JOB_ID_10460

Job Opportunity: Compliance Lead (GxP Regulatory Inspections)

We are looking for an experienced Compliance Lead to join our team for a contract position. This role is crucial for ensuring our compliance with GxP regulatory standards and facilitating audits.

Responsibilities:

• Facilitate the audit request process for GxP regulatory inspections, customer audits, and internal quality audits.
• Leverage and improve available resources to enhance compliance processes.
• Build strong relationships with system SMEs to facilitate effective audit support.
• Engage in ongoing dialogue with the compliance team to identify and implement process improvements.
• Drive the implementation of process improvements, including streamlining data collection for audit requests and proposing/implementing Smartsheet updates to minimize site data input while ensuring appropriate data capture for analytics.
• Review lessons learned to identify challenges and reduce cycle times for audit processes.
• Identify opportunities to increase the usage of the self-service portal.
• Analyze audit request data to propose improvements in expanding evidence in the self-service portal and enhancing evidence reusability.
• Execute mock audit activities as requested to ensure inspection readiness.
• Build data analytics capabilities and perform analysis on audit data, including O&F audit request data, internal quality audit observations, and external inspection data (e.g., observations, warning letters using sources like Redica).
• Identify potential gaps and remediation needs, establishing a cadence and format to share insights.
• Propose continuous improvement (CI) initiatives and execute them to completion.

Top Skills Required:

• Facilitating audit request processes for GxP regulatory inspections, customer audits, and internal quality audits.
• Executing mock audit activities to enable inspection readiness.
• Building data analytics and performing analysis on audit data.

Qualifications:

• Proven experience in a compliance or audit-related role, preferably within a GxP environment.
• Strong understanding of regulatory inspection processes and requirements.
• Experience with data analysis and reporting.
• Excellent organizational and project management skills.
• Strong communication and interpersonal skills.
• Familiarity with Smartsheet or similar project management tools is a plus.

Additional Information:

• This is a contract position.
• The role requires a hybrid presence in Chicago, IL.
• Keywords: Compliance, Lead, GxP, Regulatory Inspections, Audits, Hybrid, Chicago, IL, Contract, Data Analytics, Quality Assurance.

Compensation & Location

Salary: $55 – $75 per hour (Estimated)

Location: Chicago, IL

Recruiter / Company – Contact Information

Email: thiru.m@themesoft.com

Recruiter Notice:
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