R&D Quality Lead: Global QA & Compliance Champion

AT33 (FCRS = AT033) Novartis Pharmaceutical Manufacturing GmbH; Schaftenau; Vor Ort; EUR 78.000 - 158.000; Vollzeit

Zusammenfassung

Novartis Pharmaceutical Manufacturing GmbH, based in Schaftenau, Austria, seeks an experienced QA leader to oversee development and research quality systems. The role drives GxP compliance, regulatory alignment, and continuous quality improvement across global and regional teams.

Key duties include leading QA projects, managing audits and CAPAs, and ensuring timely investigations and robust deviations management. English language required with strong collaboration across functions.

Qualifikationen

• QA expertise in GxP and regulatory requirements.
• Experience leading QA teams and projects.
• Strong knowledge of GMP/GDP/GLP/GCP and PV processes.

Aufgaben

• Provide QA guidance to ensure compliance with quality systems.
• Lead QA organization and drive audits, inspections, and CAPAs.
• Translate QA strategy into operational activities and ensure risk-based practices.
• Support regulatory inspections and oversight of external providers.
• Ensure timely investigations and root-cause analysis for deviations.

Kenntnisse

Audit & Inspection

Quality Management

Quality Assurance

GxP Experience

cGMP

People Management

Regulatory Compliance

Quality Improvement

CAPA & Investigation

Pharmacovigilance

Risk Management

Jobbeschreibung

Novartis Pharmaceutical Manufacturing GmbH, based in Schaftenau, Austria, seeks an experienced QA leader to oversee development and research quality systems. The role drives GxP compliance, regulatory alignment, and continuous quality improvement across global and regional teams.

Key duties include leading QA projects, managing audits and CAPAs, and ensuring timely investigations and robust deviations management. English language required with strong collaboration across functions.