Global Quality Strategy & AI Governance Lead

Octapharma; Wien; Hybrid; EUR 44,000 - 53,000; Full time

Benefits offered by this job

Meal subsidy and company restaurant

Training & education

Health promotion

Parking and good transport connections

Company and team events

Job summary

Octapharma is seeking a Global Quality Strategy Expert (m/f/d) for Data Analytics & AI in Wien, AT. The role leads global quality strategy, governance, and AI-enabled systems across Clinical Data Management and analytics, driving risk-based analytics and data integrity in regulated environments.

You’ll mentor QA auditors, collaborate with Quality, Clinical Development, and Regulatory teams, and oversee GxP activities with CROs and vendors.

Qualifications

• Minimum 10 years of working experience in the Pharmaceutical or CRO Industry.
• Extensive GxP Quality Assurance and auditing experience (e.g. Clinical Data Management, Biostatistics and Statistical Programming, Computerized Systems Validation, Data Integrity).
• Demonstrated experience assessing AI/ML-enabled systems and digital technologies.
• Experience in supporting FDA, EMA, MHRA and other regulatory inspections.
• Excellent stakeholder management with the ability to influence senior internal and external partners.
• Willingness to travel internationally.

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, e.g. emerging technologies, including machine learning and generative AI applications to ensure data governance, data integrity and quality-by-design principles are embedded in digital processes.
• Drive risk-based analytics to proactively identify and manage quality risks through advanced analytical methodologies and data-driven insights.
• Evaluate AI governance controls, model lifecycle management, training data integrity, explainability, bias mitigation, and change management.
• Provide independent quality assessment of AI use cases in clinical development and operational processes.
• Monitor evolving regulatory expectations related to AI in regulated environments.
• Act as a trusted advisor to Quality, Clinical Development, Data Sciences, Digital Innovation, and Regulatory teams and present Quality Assurance in governance committees and strategic initiatives.
• Mentor QA auditors and quality professionals in digital and AI auditing methodologies.
• Lead and conduct global GxP activities and audits of CROs and technology vendors (Clinical Data Management, Biostatistics and Statistical Programming, Electronic Data Capture (EDC) systems, Clinical databases, AI/ML-enabled platforms, Computerized systems and cloud-based technologies)

Skills

Stakeholder management

Strategic thinking

AI governance familiarity

Data governance

Regulatory liaison

Communication skills

Education

Degree in Life Sciences or related field

Job description

Octapharma is seeking a Global Quality Strategy Expert (m/f/d) for Data Analytics & AI in Wien, AT. The role leads global quality strategy, governance, and AI-enabled systems across Clinical Data Management and analytics, driving risk-based analytics and data integrity in regulated environments.

You’ll mentor QA auditors, collaborate with Quality, Clinical Development, and Regulatory teams, and oversee GxP activities with CROs and vendors.