Job Overview Lead and support effective corrective and preventive action (CAPA) management for significant quality issues (QIs) and audit and inspection responses including the assessment and review of investigations, appropriate root cause analysis and corrective and preventative actions. Provide support to management with insights, analyses and assessment and promotion of compliance with regulations, guidelines, and operating procedures through risk identification and mitigation, and improvement initiatives. Manage the quality assurance oversight of quality issues, audit responses, assignments, training and staff. Oversee and lead team management activities.Essential FunctionsLead and mentor members of the CAPA management team, with a focus on driving improvement and compliance, ensuring an aligned approach to CAPA management and adherence to regulations and guidelines and providing support as needed. Lead and support CAPA activities for complex QIs and sponsor audits and inspections: assessing investigations, ensuring appropriate root cause analysis is performed,
adequate corrective and preventative actions and effectiveness are implemented and followed up within the agreed timelines Collaborate with cross-functional stakeholders to identify process gaps, areas of improvements and ensure the application of quality processes, principles and strategy to support compliance with relevant regulations, GCP guidelines, procedures and sponsor agreements Ensure proper reporting and documentation of CAPAs in the electronic quality management system (eQMS) and that robust corrective and preventative actions and effectiveness checks are tracked and completed within the required timelines Promote a culture of proactive and continuous process improvement by identifying risks and trends, and optimizing the CAPA system and processes. Lead with a spirit of teamwork and collaboration to ensure effective communication among all department stakeholders and staff. Develop and/or prov