About this role
Location: Schaftenau, Austria #onsite
Role Purpose: Provide quality assurance and compliance oversight for development and research functions. Ensure compliance with regulatory requirements and Novartis quality standards, promote a quality-focused culture, and support Quality Plan initiatives aligned with organizational goals.
Major Accountabilities: o Ensure compliance with quality systems, GxP requirements and risk-based processes o Lead QA organizations and quality project teams o Translate QA strategy into operational compliance activities o Identify and close quality and compliance gaps o Support inspections, audits and regulatory readiness o Oversee external service providers and IT systems supporting R&D o Manage deviations, incidents, investigations and corrective actions o Promote proactive, risk-based quality behavior o Report technical complaints and adverse events within required timelines o Distribute marketing samples where applicable
Key Performance Indicators: o High-quality and timely project documentation and presentations o Reliable and accurate communication with stakeholders o Delivery against departmental budget and succession planning objectives o Role model of Novartis culture, values and behaviors
Work Experience: o Quality Assurance and Quality Management Systems o Audit and Inspection Management o GxP and cGMP Compliance o Drug Development and Research o People Management o Complaints, Incident and Deviation Management o GLP Analytics and Pharmacovigilance
Languages: o English
Adjustments for Applicants with Disabilities: If you require an adjustment during the recruitment process due to a medical condition, physical disability or neurodiverse condition, please contact [email protected] with details of your request and contact information.
Division: Development
Business Unit: Quality
Location: Austria
Site: Schaftenau
Company / Legal Entity: AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH
Apply To The Job: https://www.novartis.com/careers ; Job ID: REQ-10076867