R&D Quality Lead

Novartis; Langkampfen; Vor Ort; EUR 70.545 - 86.222; Vollzeit

Zusammenfassung

Novartis seeks a Quality Assurance professional in Langkampfen, Austria, to provide oversight for compliance with health authority regulations and quality standards. The role encompasses leading quality initiatives, managing audits, and ensuring continuous improvement in quality management systems. Candidates should possess extensive experience in quality assurance, GxP frameworks, and audit management. A competitive salary starting at €78,383.90 is offered, reflecting the candidate's experience and qualifications.

Qualifikationen

• Experience in managing quality compliance and assurance in a regulated environment.
• Ability to conduct robust investigations, root cause analyses, and implement corrective actions.
• Skilled in driving quality initiatives and managing auditing processes.

Aufgaben

• Provide QA expertise to ensure compliance with quality systems.
• Lead QA teams and projects ensuring regulatory requirements are met.
• Monitor implementation of Quality Plans and preparation for inspections.

Kenntnisse

Audit & Inspection Management

Quality Management Systems

Quality Assurance

GxP Experience

Good Manufacturing Practices (cGMP)

People Management

Quality Compliance

Drug Development

Research

Technological Expertise

Complaints Management

Good Laboratory Practice (GLP)

Incident Management

Deviation Management

Patient Safety

Pharmacovigilance

Jobbeschreibung

Role Purpose

Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Novartis procedures and quality standards. Role model good quality behaviors while promoting a culture of quality to positively impact non‑quality stakeholders. Develop, drive and support quality plan initiatives to achieve organizational strategy, mission and vision.

Location

Schaftenau, Austria (onsite)

About The Role

Major Accountabilities

• Provide QA expertise and guidance to ensure compliance with quality system requirements, including implementation of quality risk‑based and GxP relevant processes.
• Lead and manage a QA organization and/or quality project team and collaborate with business partners and other quality groups to ensure health authority and regulatory requirements are fully met.
• Translate functional QA strategy into applicable operational/compliance activities and support a risk‑based implementation and execution of processes.
• Ensure quality and compliance gaps are addressed and executed, implement strategic process improvement, including review of procedural updates, training, process improvement, effectiveness checks, etc.
• Monitor implementation of the Quality Plan and support inspection readiness activities, including participation in regulatory inspection preparation, management and follow‑up.
• Support quality oversight/management of external service providers and IT systems supporting research and development activities and drive facilitation and follow‑up of audits and inspections, and ensure development, implementation and completion of appropriate corrective and preventive measures for findings.
• Ensure timely escalation of deviation/incidents and provide quality oversight for deviations/incidents, including robust investigations, root cause analysis and corrective actions implementation.
• Contribute towards lessons learned based on audits, inspections, incidents, regulatory intelligence, effectiveness checks on process implementations and metrics and support a culture of proactive, risk‑based behaviour.
• Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribution of marketing samples (where applicable).

Key Performance Indicators

• Quality and timelines of strategic project documentation and presentations: Documentation available on time and of high quality.
• Reliable, timely and accurate information/communication about project specific issues and to key stakeholders.
• Deliver on department’s cost/budget and establish succession plan.
• Role model of Novartis culture, values, and behaviours.

Work Experience

• Audit & Inspection Management
• Quality Management Systems
• Quality Assurance
• GxP Experience
• Good Manufacturing Practices (cGMP)
• People Management
• Quality Compliance
• Drug Development
• Research
• Technological Expertise
• Complaints Management
• Good Laboratory Practice (GLP) Analytics
• Incident Management
• Deviation Management
• Patient Safety
• Pharmacovigilance

Languages

• English

Compensation

In accordance with Austrian law, the minimum salary for this position is €78 383.90 per year (full‑time). The actual salary will be significantly higher, reflecting experience, qualifications and competencies.

Adjustments for Applicants with Disabilities

If you require an adjustment during the recruitment process due to a medical condition, physical disability or a neurodiverse condition, please contact [e-mail] with details of your request and contact information. We can provide advice on suitable positions and guidance at all stages of the application process. Austrian law allows candidates to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, let us know in advance as a note on your CV.