ESO AS&T Manager

Responsible for implementing and maintaining the ESO AS&T quality system including tools & processes. Responsible for analytical activities in the scope of ESO (e.g. QC activities and stability programs) and providing technical support to suppliers in scope.

Major AccountabilitiesLead, implement and reports on global AS&T requirements/programs in the assigned ESO QA Network. Supports defining and implementing business processes and SOPs/GOPS necessary to maintain a robust AS&T Quality System within External Supply (e.g. data integrity, analytical change management)Escalates any analytical issues or instances of instability per the Novartis escalation policy, initiates any market action as required.Owns and maintains testing monographs for products in scope of ESOEnsure Testing Monographs are state-of-the-art with respect to technique and technology, and in line with registration documentation. This includes, but not only, reviewing registration documents and being in line with pharmacopeia standards.Supports the accountable QAM to define and maintain the ESO Stability Program at CMOs, ensures that Stability Programs are state-of-the-art with respect to HA requirements and in line with registration documentation. Leads programs and initiatives to implement changes and remediation as required.Interprets stability data, analyses trends, and provides scientifically sound conclusions for product shelf life/re-test assessments, storage conditions and packaging and transport categories. Defines corrective actions to address immerging stability issues together with MS&T.Supports and drives analytical trouble shootingOwns and/or ensures analytical investigations are managed in agreement with cGxP standards and the right CAPAs are implemented.Acts as SPOC for analytical subjects in cross functional ESO AS&T project teamsOwns tech transfer assessments for analytical method transfers or new analytical methods.Owns changes regarding analytics and/or provides the required assessments in regards to analytics during general change control activities. Defines studies/assessments needed to support changes regarding analytics.Supports implementation of guidelines at the assigned external partners and suppliersProvides the analytical input required for External Suppliers Qualification processSupports site readiness for Health Authority inspections & participate in audits on request.Key Performance Indicators Number and severity of AS&T related cGMP issues identified during audits (internal, GCA, HA)ESO performance evaluated by the department KQIsState of the art of stability program for contractors and testing monographsSpecific Professional CompetenciesDeep knowledge of GMP and regulatory requirements (FDA, EU, MHRA, etc.)Good communication and interpersonal skillsStakeholder (internal and external) management