Job Code: YX04-08
The Biotherapeutics Development Unit is seeking a senior Quality Assurance leader responsible for the efficient operation of all quality aspects (cGMP/cGLP/cGCP) for the unit in accordance with the Novartis Quality System requirements ensuring high product quality, regulatory compliance, and operational efficiency. The incumbent will work directly with the discovery and development project/program teams to develop Quality strategy and provide guidance for biologics drug development, including senior level input in support of preclinical/early/full development, registration, and approval/post-approval activities. Additionally, the incumbent will have Quality oversight of several programs including development of quality strategy, preparation of the Health Authority submissions, and collaborates with internal and external partners for inspections under the strategic and functional leadership of the senior management of Novartis Group Quality and Biologics Quality in Pharma Development including evaluate in-licensing opportunities and carry out Due Diligence activities as required.
• Scientific degree from accredited Technical University, preferably in Microbiology, Chemistry or Pharmacy
• Must be fluent in English both oral and written
• At least 10 years experience in Quality Assurance/ Quality Control environment in differing responsible management functions within the pharmaceutical industry
• Detailed knowledge of drug development processes and worldwide regulatory guidelines are essential
• Experience with diverse biotherapeutics portfolio especially on antibody, antibody drug conjugate and complex biologics highly desirable
• Previous experience interfacing and guiding CRO activities related to clinical and preclinical study operations, as well as technical development and clinical trial material supply at CMO highly desirable
• Extensive international working experience with regulatory agencies in Europe as well as in the US preferable
• Previous experience with early and late stage development, as well as post-approval activities a plus
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