Compliance Lead

Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits. Develop a strong understanding of 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 system SMEs to fulfill audit requests; elevate 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. 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. Review lessons learned to identify challenges and reduce cycle times. Identify opportunities to increase self-service portal usage. Analyze audit request data to propose improvements in expanding evidence in self-service portal, reusability of evidence, etc. Execute mock audit activities, as requested, to enable inspection readiness. Build data analytics and perform analysis on audit data. Internal quality audit observations. External inspection data, including observations and warning letters, using available sources, e.g. Redica. Identify potential gaps/remediation needs; establish cadence and format to share insights. Improvement opportunities (proactively addressing gaps based on regulatory insights); frame opportunities for consideration by appropriate Quality System CoE. Propose continuous improvement (CI) initiatives and execute initiatives to completion. Responsibilities Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits. Develop a strong understanding of 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 system SMEs to fulfill audit requests; elevate 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. 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. Review lessons learned to identify challenges and reduce cycle times. Identify opportunities to increase self-service portal usage. Analyze audit request data to propose improvements in expanding evidence in self-service portal, reusability of evidence, etc. Execute mock audit activities, as requested, to enable inspection readiness. 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. Identify potential gaps/remediation needs; establish cadence and format to share insights. Improvement opportunities (proactively addressing gaps based on regulatory insights); frame opportunities for consideration by appropriate Quality System CoE. Propose continuous improvement (CI) initiatives and execute initiatives to completion. Requirements: Facilitate audit request process for GxP regulatory inspections, customer audits, and internal quality audits. Execute mock audit activities, as requested, to enable inspection readiness. Build data analytics and perform analysis on audit data. Years of Experience: 8+ Years of Experience. #J-18808-Ljbffr