Director, Development Quality Assurance: Regulatory Affairs

hace 2 meses

Barcelona, España Director File A tiempo completo

.As part of the Development Quality Assurance Team, you will drive Quality Culture with stakeholders by partnering on quality topics, embedding a quality mindset, and executing on continuous improvement opportunities. You will be responsible for managing business relationships with defined stakeholder groups and leaders in Development, Regulatory and Safety functions and for the strategic development and delivery of risk-based quality management and global regulatory affairs quality oversight for internal and external business partners.You will be responsible for: Business PartneringProvide responsive and proactive quality and compliance advice to stakeholder groups, effectively influencing assigned area by being relevant GxP expert.Provide effective compliance reporting to senior management and supports strategic QA governance forums.Drive the quality management system governance model for the Alexion Rare Disease Unit (ARDU) in line with AZ Standards.Regulatory Affairs Quality OversightPartner with Global Regulatory Affairs (GRA) and functional personnel to implement and support quality and compliance standards in accordance with global regulatory requirements and Alexion/AZ values. This includes working effectively with GRA stakeholders to understand functional interdependencies and to develop mutually agreed optimized processes.Assure effectiveness of business processes and compliance with adequate regulations.Support the CAPA investigation, review, and approval process for GRA-owned Quality Events (including audit and inspection findings and deviations).Collaborate with GRA on Standard Operating Procedure (SOP) development serving as quality approver.Quality ManagementOversight and monitoring of the ARDU Quality Management System (QMS) to enable a quality culture and promote continued compliance.Establishing, monitoring, and reporting of Key Quality Performance Indicators and metrics to meet business needs and regulatory requirements.Providing proactive interpretation of quality and compliance metrics data for inclusion in periodic reports and dashboards.Assure effectiveness of business processes and compliance with adequate regulations.Drives continuous process improvement with simplification, standardization, and improved user experience in collaboration with functions/system and business process owners.Drive strategy to ensure learning curricula are fit for purpose for job roles.General AccountabilitiesEnsuring own tasks are performed to current practices and in accordance with company policies, standards, SOPs, and guidelines.Assists in inspection readiness and preparation, and/or directly supports regulatory agency inspection. Assists in coordination of responses to any findings, as applicable.Contributes to Due Diligence activities.Accountable for development, coaching, and mentoring of assigned staff and achievement of performance standards, capability, and effective line management

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