R&D Quality Lead (m/f/d)

Novartis Pharmaceutical Manufacturing GmbH 1 R&D Quality Lead (m/f/d) 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 Das Mindestentgelt für die Stelle als R&D Quality Lead (m/f/d) beträgt 78.383,90 EUR brutto pro Jahr auf Basis Vollzeitbeschäftigung. Bereitschaft zur Überzahlung.