Global Quality Strategy Lead – AI & Data Analytics

Octapharma-Plasma; Wien; On-site; EUR 44,000 - 53,000; Full time

Benefits offered by this job

Company restaurant & meal subsidy

Training & further education

Health promotion

Parking spaces and good public transit

Company and team events

Job summary

Octapharma, a leading human protein manufacturer, seeks a Global Quality Strategy Expert (m/f/d) to drive the data analytics and AI governance strategy across Clinical Data Management, Biostatistics and digital platforms. You will oversee AI-enabled systems, ensure data governance and quality-by-design principles, and lead QA audits of CROs and vendors.

The role requires a minimum of 10 years in pharma/CRO, strong GxP QA experience, and fluency in English (German a plus).

Qualifications

• Minimum 10 years in the pharmaceutical or CRO industry.
• Extensive GxP QA and auditing experience (Clinical Data Management, Biostatistics, Computerized Systems Validation).
• Experience assessing AI/ML-enabled systems and digital technologies.
• Experience supporting FDA/EMA/MHRA inspections or other regulatory bodies.
• Excellent stakeholder management and ability to influence senior partners.

Responsibilities

• Develop and implement the global quality strategy, oversight models and frameworks for Clinical Data Management, Governance, Analytics, Biostatistics, Digital Technologies and AI-enabled systems.
• Provide quality leadership for digital transformation initiatives and AI governance to ensure data integrity and quality-by-design.
• Drive risk-based analytics to identify and manage quality risks through advanced analytics and data-driven insights.
• Evaluate AI governance controls, model lifecycle management, data integrity and explainability.
• Provide independent quality assessment of AI use cases in clinical development and operations.
• Monitor evolving regulatory expectations related to AI in regulated environments.
• Act as trusted advisor to Quality, Clinical Development, Data Sciences and Regulatory teams and present QA in governance committees.
• Mentor QA auditors and quality professionals in digital and AI auditing methodologies.
• Lead and conduct global GxP audits of CROs and technology vendors.

Skills

Stakeholder management

Strategic thinking

Auditing leadership

Machine learning basics

Regulatory knowledge

Data analytics

Cross-functional collaboration

Communication skills

Education

Degree in Life Sciences/Statistics/CS/Data Science/Quality Management

Tools

EDC systems

AI governance platforms

Clinical data management tools

Job description

Octapharma, a leading human protein manufacturer, seeks a Global Quality Strategy Expert (m/f/d) to drive the data analytics and AI governance strategy across Clinical Data Management, Biostatistics and digital platforms. You will oversee AI-enabled systems, ensure data governance and quality-by-design principles, and lead QA audits of CROs and vendors.

The role requires a minimum of 10 years in pharma/CRO, strong GxP QA experience, and fluency in English (German a plus).