What are the responsibilities and job description for the Compliance Lead position at Katalyst CRO?
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.
- 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.