NEWPosted 6 hours ago
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:
To remove this job posting, please send an email from
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