Global Quality Strategy Lead: AI, Data & GxP Governance

Octapharma Austria; Wien; Presencial; EUR 44.000 - 53.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Meal subsidy

Training programs

Health initiatives

Parking & transport

Team events

Descripción de la vacante

Octapharma Pharmazeutika Produktionsges.m.b.H. in Vienna seeks an experienced QA leader to shape the global quality strategy for Clinical Data Management, Governance, Analytics, Biostatistics, and AI-enabled systems.

You will guide digital transformation while ensuring data integrity and compliance across a multinational scope. You will assess AI use cases, oversee model lifecycle and regulatory interactions, and mentor auditors.

Formación

• Minimum 10 years in pharmaceutical or CRO sectors.
• Extensive GxP QA and auditing experience.
• Proven experience evaluating AI/ML-enabled systems.
• Experience supporting FDA/EMA/MHRA inspections.
• Strong stakeholder management and planning skills.
• Fluent in English; German a plus.

Responsabilidades

• Develop and implement global quality strategy for Clinical Data Management, Governance, Analytics, Biostatistics, Digital Technologies and AI-enabled systems.
• Provide quality leadership for digital transformation initiatives and AI governance.
• Drive risk-based analytics to identify and manage quality risks.
• Evaluate AI governance, model lifecycle, data integrity, explainability.
• Provide independent QA assessments of AI use cases in clinical development.
• Monitor evolving regulatory expectations related to AI.
• Advise Quality, Clinical Development, Data Sciences, Digital Innovation, Regulatory teams.
• Mentor QA auditors in digital and AI auditing methodologies.
• Lead global GxP activities and audits of CROs and technology vendors.

Conocimientos

Quality Assurance

GxP Compliance

AI Governance

Data Governance

Stakeholder Management

English Fluent

Willing to Travel

Educación

Degree in Life Sciences/Statistics/CS/Data Science

Herramientas

GxP Audit Tools

Descripción del empleo

Octapharma Pharmazeutika Produktionsges.m.b.H. in Vienna seeks an experienced QA leader to shape the global quality strategy for Clinical Data Management, Governance, Analytics, Biostatistics, and AI-enabled systems.

You will guide digital transformation while ensuring data integrity and compliance across a multinational scope. You will assess AI use cases, oversee model lifecycle and regulatory interactions, and mentor auditors.