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Apply to JobJob ID251233BRPosition TitleManager Operations & Ext. Service QAJob DescriptionThe Operations and External Service Quality Manager is responsible for the execution of quality processes, tools and systems used in managing external service providers (ESP) across non-GxP and GxP areas of NIBR to assure compliance with applicable Standard Op-erating Procedures (SOP), GLP/GCLP regulatory and Novartis requirements. The role supports quality oversight of NIBR Laboratory external service providers (Research labs, GLP Labs, Clinical Labs, Biomarker, etc) and NIBR vendors from initial assessment, inspection management, execution of Study based audits, day-to-day oversight and risk-based quality monitoring. The role requires effective collaboration with assigned NIBR business partners responsible for day-to-day ESP oversight and ESPs.



Major Accountabilities

1. Coordinates and manages Quality forum activities with NIBR external service provid-ers to enable evaluation of KQIs, detection of risks, trends and to identify potential quality and performance issues with the ESP in a proactive manner.

2. Executes relevant vendor oversight quality activities as outlined in oversight proce-dures.

3. Collaborates with internal business partners, R&D Procurement and other Novartis functions to participate in vendor selection and strategic planning, review quality re-quirements, perform risk evaluation and follow-up on required actions.

4. Oversight for ESP deviation/incident management including timely escalation when required and associated resolution.

5.Responsible for the collection, monitoring and reporting of the key quality attributes metrics for the ESPs. This includes any required follow up and escalation together with NIBR business partners to close any identified trends/gaps.

6. Execute/provide support for the qualification, periodic audits and monitoring as-sessments of the NIBR ESPs.

7. Assist in the preparation of inspections by Health Authorities of Pre-clinical and Clin-ical Lab ESPs related to Novartis Studies.

8. Conduct/support inspections of internal study activities, facilities and systems in-cluding reporting of QA findings for GLP areas, as required by applicable SOPs to the applicable Study Director and Management.

9. Lead/support internal continuous improvement initiatives.Minimum requirements5+ Demonstrated quality/operations experience working in a pharmaceutical industry with knowledge of preclinical safety, toxicology studies and pre-clinical bioanalytics.

Broad understanding of Industry Quality Standards and International Regulations (OECD, FDA, GLP, GCP).

Expertise in the conduct of internal facility and external quality audits

Fluency in English (oral and written). Additional languages such as Mandarin are a plus.DivisionNIBRBusiness UnitNIBR QUALITY & COMPLIANCELocationSwitzerlandSiteBaselCompany/Legal EntityNovartis Pharma AGFunctional AreaQualityJob TypeFull TimeEmployment TypeRegular

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