Qualitätssicherungstechniker/in

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/career-search/job/details/req-10076867-rd-quality-lead