DIRECTOR, GLOBAL STERILITY ASSURANCE TEAM LEAD

Summary As Director, Global Sterility Assurance Team Lead you will.
• Lead a team (4-6 direct reports, indirect) of Key functional Expert for Aseptic processing within the Novartis manufacturing network (includes Large Molecules and Advance therapies and third parties producing for Novartis).
• Ensures and verifies 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.
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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.
Overall team leader that has the responsibility of 4-6 individual contributors hosted in US, Spain and Austria, plus indirect reports located within the manufacturing sites performing sterile operations.
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.
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storyboards for complex cases, etc.) Primary Responsible for optimization of aseptic processes (as e.
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cleaning and disinfection programs, microbiological monitoring and sterilization techniques) between sites and platforms within the Novartis manufacturing network Support escalations for specific topics (i.
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Microbial contaminations, sterility issues, etc.) with the manufacturing sites if needed, and in collaboration with the other members of the platform (i.
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QA operations, QA compliance lead, QC/AS&T lead) Own, Monitor and act as Primary contact for the sterility assurance from the sites and define improvement plans as appropriate.
Build fit for purpose aseptic governance and training program in collaboration with engineering and MS&T to support sites in development, training and understanding of aseptic topics Provides input for the selection, training, people development and performance evaluation, development planning and participating in recruiting process of the Aseptic experts within the manufacturing sites / global functions.
Obligatory requirements.
Education.
Graduate in Chemistry, Pharmacy, Microbiology or another related science; desirable.
Ph.
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in science or related discipline years experience in management and leadership roles in the pharmaceutical industry, preferably in a FDA-regulated environment and in QA Operations & Compliance of a strategic Site or a global role.
Pharma production experience indispensable.
Quality Assurance / cGMP regulations in USA, EU (Self Inspections, Auditing of 3rd parties, Complaint/Deviation Handling, GMP-Training, SOP-Systems).
Deep understanding of microbiology and aseptic processes Solid People Management / Communication skills (To explain difficult business processes and related GMP-requirements to a community of very diversely oriented and educated people from a multitude of different units.
Excellent Project Management skills, especially with crossfunctional projects.
Fluent English written and spoken.