Quality Manager Pilot Plant

Job description

Job Description Summary Location: Schaftenau, Austria #onsite Role Purpose: Provide quality assurance expertise, guidance and support to operational activities in development and research organizations to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards. This person will manage projects, including Quality Plan initiatives, and processes that support quality objectives to assure their compliance with GxP regulations. Job Description: Major Accountabilities: - Support maintenance of the regulatory -required files for health authority inspections and assist with health authority inspection management - Support generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs - Support initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems - Support initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements - Ensure information gained dur...