Compliance Lead (GxP regulatory)

Chicago, IL - USA

Monthly Salary: Not Disclosed

Posted on: 4 days ago

Vacancies: 1 Vacancy

Job Summary

Job Title: Compliance Lead
Location: Chicago IL (Hybrid)
Job Type: Contract

Skill Metrics:

Audit & Monitoring
Cornerstone On Demand LMS
FDA 21 CFR
GxP Assessment
Data Analytics

Top skills required for this role:
1. Facilitate audit request process for GxP regulatory inspections customer audits and internal quality audits.
2. Execute mock audit activities as requested to enable inspection of readiness.
3. Build data analytics and perform analysis on audit data.

Job Description/ Responsibilities:
Facilitate audit request process for GxP regulatory inspections customer audits and internal quality audits:
Develop a strong understanding of AbbVies SLC and system evidence to support audits
Leverage available resources and improve resources to enhance or maintain with changes in environment
Coordinate audit support activities with appropriate AbbVie system SMEs to fulfill audit requests; escalate risks and issues to ensure timely resolution/responses in alignment with agreed SLAs.
Build relationships with system SMEs to facilitate the audit support process
Engage in ongoing dialogue with compliance team to identify and obtain alignment on process improvements.
Drive implementation of process improvements:
o Streamline data collection of audit requests propose and implement Smartsheet updates to minimize site data input while ensuring appropriate data is captured for beneficial analytics
o Review lessons learned to identify challenges and reduce cycle times
o Identify opportunities to increase self-service portal usage
o Analyze audit request data to propose improvements in expanding evidence in self-service portal reusability of evidence etc.
Build data analytics and perform analysis on audit data:
O&F audit request data
Internal quality audit observations
External inspection data including observations and warning letters using available sources e.g. Redica

Job Title: Compliance Lead Location: Chicago IL (Hybrid) Job Type: Contract Skill Metrics: Audit & Monitoring Cornerstone On Demand LMS FDA 21 CFR GxP Assessment Data Analytics Top skills required for this role: 1. Facilitate audit request proce...