Quality Manager, CAPA Centre of Excellence (CCoE)

Job description

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 Functions: Lead 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...