Compliance Lead

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; 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.
• 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.