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Job ID197685BRPosition TitleOperations and Strategy Head, NBS QADivisionNBSBusiness UnitNBS QUALITYCountrySwitzerlandWork LocationBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegularJob DescriptionFacilitate the definition and lead the implementation and integration of all Quality strategic initiatives and programs within in the areas of NBS Product Lifecycle Services (PLS), Real Estate and Facility Services (REFS) and IT. Support the implementation of the Novartis Quality Strategy within relevant NBS Domains: PLS, REFS and IT. Define and implement consistent Key Quality Indicators (KQIs) in PLS, REFS and IT; build related reporting systems and ensure consistent tracking. Provide project support for REFS/REFS QA and support life-cycle management approaches for service providers and other REFS services.
1. Facilitate the definition and lead the implementation of Quality strategic initiatives and programs including relevant elements of the Novartis Quality Strategy within in the areas of NBS Product Lifecycle Services (PLS), Real Estate and Facility Services (REFS) and IT.
2. Support the integration of the quality strategy into the relevant NBS domains strategies.
3. Build and implement consistent Key Quality Indicators (KQIs) in PLS, REFS and IT; build related reporting systems and ensure consistent tracking.
4. Manage relevant NBS-QA lead team and Quality Governance Meetings and develop presentations for all relevant operational and strategic meetings.
5. Support the implementation of the NBS Quality Management System in PLS, REFS and IT. Support the end-to-end process standardization including the link to IT.
6. Collaborates effectively with stakeholders in NBS domains and PMO network within Quality.
7. Maintain the QA resource plans for the domains in line with respective business plans and priorities.
8. Provide project support for REFS/REFS QA and quality oversight for REFS including the implementation of life-cycle management approaches for service providers and other REFS services. Provide quality performance and compliance reviews for the management of service providers and other REFS services.
9. Provide support for audit- and inspection-readiness on an ongoing basis and in close collaboration with relevant NBS domains. Ensure identified improvement actions following audit observations related to GxP service providers and related activities are implemented.
10. Design and drive the NBS QA communication plan and stakeholder management across all GxP relevant NBS domains. Manage executive communications, including reporting and/or updates of monthly reports, Quality Plan, projects status, announcements, etc. to NQLT, NBS management, and other stakeholders.
11. Provide operational support to NBS QA to achieve departmental objectives and targets.
1. Relevant quality initiatives are effectively managed across the NBS domains PLS, REFS and IT.
2. Consistent tracking and reporting systems are built and KQIs in the areas of PLS, REFS and IT implemented, trended and any potential issues proactively identified and escalated.
3. Quality support of REFS vendor management is effectively provided. Gaps and risks are identified and escalated to REFS QA and REFS management, as appropriate.
4. NBS REFS projects deliverables and milestones are consistently met.
5. Customer/stakeholder satisfaction and corresponding feedback.Minimum requirementsDegree in Life Sciences, Pharmacy, Engineering; advanced degree preferred Fluency in English (oral and written), additional language(s) a plus
• A minimum of 8 years of relevant experience in the Pharmaceutical Industry and in particular in regulated functions such as Quality and/or Engineering
• Profound understanding of global regulations and Health Authorities expectations governing out-sourcing of services and related activities
• Experience in vendor quality management in the Pharmaceutical Development, Manufacturing and Quality space
• Proven successful cross-divisional/cross-functional work within complex international and multidisciplinary teams
• Proven ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude.
• Ability to effectively interact with and present to Senior Management, as well as to external audiences and health authority inspectors.
• Able to engage with globally remote and culturally diverse teams.