Summary
As Director, Global Sterility Assurance you will:
Be Key functional Expert for Aseptic processing within the Novartis manufacturing network (includes Large Molecules and Advance therapies / CMO sites with focus on Large Molecule manufacturing sites.Ensure and verify that all actions related to FDA and other health authority inspections are understood and implemented by the sites in the platform, avoiding re-occurrence of 483's and Warning Letters.Assure that key projects are implemented in the manufacturing sites as per committed plan to FDA and other health authorities.Ensure implementation of changes to support GMP updates (i.e.
Annex 1) within all the sites in scope in order to assure ongoing compliance for the upcoming years.
In this regard supports the gap assessment process and respective remediation and action tracking.Liaise with TechOps to ensure implementation, follow up and completeness of all related Quality/ Compliance programs, documentation and Quality reporting of Aseptic related projects / metrics.Ensure adequate Health Authority Inspection preparation of the Sites in scope and successful inspection outcomes.
Interactions with sites mainly require interpretation of complex information and persuasion both internally with other areas of the business and the site leadership team and externally.About the Role Major Accountabilities: Lead cross site/platform and network projects and harmonization initiatives as assigned.Provide expert advice and appropriate technical support to ensure site readiness for Health Authority and GGA inspections by supporting sites in their preparation, up to and including hands on preparation of materials (i.e.
storyboards for complex cases, etc.
).Ensure quality actions are executed and the overall plans are closed per the required timelines and that future quality plans are aligned with global initiatives.Primary Responsible for optimization of aseptic processes (as e.g.
cleaning and disinfection programs, microbiological monitoring and sterilization techniques) between sites and platforms within the Novartis manufacturing network.Aseptic operations support for ramp up of new production facilities and microlabs.SME in microbiological topics, provide ad-hoc support to the sites of the platform and within the network.Support escalations for specific topics (i.e.
Microbial contaminations, sterility issues, etc.)
with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.e.
QA operations, QA compliance lead, QC/AS&T lead).Setup system to capture lessons learned (e.g.
topics discussed, near misses) during internal and external audits and define appropriate actions.Share best practices between the different sites and ensure cross platform communication with aseptic sites (e.g.
by authoring Novartis position papers).Manage escalations for specific topics (i.e.
Microbial contaminations, sterility issues, etc.
).
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