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.Associate Director, External Service Provider Quality Job ID REQ-10019461Aug 28, 2024United KingdomSummary Primary Location: London Westworks, United KingdomAlternate Location(s): Dublin, Ireland / Barcelona, Spain / Madrid, SpainWorking model: All locations have a hybrid working model (12 days per month in the office)Note: Novartis is not able to offer relocation for this role. Please only apply if the location is accessible for you and you have the right to work in the country you are applying to.About this role:As our Associate Director External Service Provider QA, you'll have the thrilling opportunity to oversee the implementation of top-notch quality standards, cutting-edge processes, and innovative tools and systems.You will play a pivotal role in managing external service providers across GxP areas in Global R&D Quality, ensuring that our partners meet the highest standards of excellence.About the Role Major accountabilities:Provide QA expertise and guidance to ensure compliance with requirement of the quality system are met, including implementation of quality risk-based and GxP-relevant process. Review and approval of External Service Providers (ESP) qualifications. Responsible for adequate Quality Assurance Agreements (QAA) / quality terms with ESPs are in place.Lead and manage a quality oversight and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met. Translate functional QA strategy into applicable operational/compliance activities and support a risk-based implementation and execution of processes.Review and approval of external service provider Quality Risk Assessments (QRAs) to enable identification and evaluation of various metrics, risks, trends, and potential quality and performance issues with the ESP in a proactive manner. Ensure communication and support mitigation of actions for potential risks.Ensure quality and compliance gaps are addressed and executed for sustainability and implement strategic process improvement, including review of procedural updates, quality issues, effectiveness checks, etc. Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management, and follow-up. Support Audit team for audit planning and timely completion of audit CAPA.Support clinical trial team for oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow-up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings. Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation
