Global Quality Strategy Expert (m/f/d) - Data Analytics & AI

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

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Global Quality Strategy Expert (m/f/d) - Data Analytics & AI

Job ID: 63906

Location: Wien, AT

Job Level: Professionals

Job Category: Research and Development

Become part of a vital chain and contribute to our common goal of making people’s lives better. Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

With over 1700 employees, the Octapharma site in Vienna is the largest production site, and successful research and development location.

Your main tasks and 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)

Your expertise and ideal skill set

• Completed degree in Life Sciences, Statistics, Computer Science, Data Science, Quality Management, or related discipline
• At least 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 skills with the ability to influence senior internal and external partners
• Excellent organizational skills, a proactive mindset and the ability to manage multiple strategic priorities
• Fluent in English, German is a plus (written and oral)
• Willingness to travel internationally as required

Your department - where you make an impact

• We, the Research & Development unit, conduct preclinical and clinical research to develop new products and ensure their safe and effective use. Our ultimate focus in our daily work is to enhance patient health and safety.

Thrive with us

• Company restaurant & meal subsidy
• Training & further education
• Health promotion
• Parking spaces and good public transport connections
• Company and team events

Enjoy these attractive benefits! You can find all offers here: Benefits The minimum gross salary according to the collective agreement (chemical industry) is EUR 4.355,55 based on 38 hours per week (full-time). As we strive to offer a salary that reflects your individual profile and qualifications, there is a willingness to pay above the minimum salary.

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.

Do you have any questions? Then get in touch with your contact person.

Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 200 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.