Lead the development and implementation of the quality strategy and compliance standards, quality governance and quality processes applicable for all regulated GxP activities. Lead the effective implementation of all quality requirements across the site to ensure that systems and business processes are compliant with Quality and regulatory requirements. Drive implementation and reporting of adequate quality governance and respective metrics to create transparency for the overall quality and compliance status of site activities. Identify and drive implementation of risk-based approaches and continuous improvement opportunities.
- Successful implementation of applicable quality and compliance standards, governance and processes governing self-assessments, quality control and CAPA management.
- No overdue Health Authority commitments for site activities. No overdue audit CAPAs (i.e. critical and major findings) for site activities. Effective and timely closure of audit CAPAs.
- Reporting processes for out-of-compliance metrics, ensuring they are implemented and reported as required per established timelines. Overall compliance status is achieved as per defined targets levels.
- Key Quality Indicators are implemented, tracked and assessed to proactively identify areas of potential risks and opportunities for continuous improvement. Potential compliance risks are proactively identified and escalated.
- Training on quality standards is consistently and fully deployed in the site; appropriate KPIs are implemented and routinely monitored. Ownership of all compliance issues and timely escalation.
- Leadership of all HA inspections regarding preparation, facilitation, response creation and definition of corrective and preventive actions; timely and comprehensive fulfillment of HA commitments.