Job
In this role, you will develop the global quality strategy for clinical data and digital technologies, conduct quality assessments of AI applications, and support digital transformation projects to ensure data integrity.
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Your role in the team
- 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 represent 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).
Our expectations of you
Education
- Completed degree in Life Sciences, Statistics, Computer Science, Data Science, Quality Management, or a related discipline.
Qualifications
- 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 spoken).
- Willingness to travel internationally as required.
Experience
- At least 10 years of work 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.
What we offer
- The minimum gross salary under the collective agreement for the chemical industry is EUR 4,355.55 for a 38-hour workweek (full-time).
- As we strive to offer a salary that reflects your individual profile and qualifications, we are willing to pay above the minimum salary.
Benefits
Food & drink
Health, fitness & fun
Topics you will work on
Job locations
About your employer
Wien
Since its inception in 1983, Octapharma has focused on the development and production of preparations made from human plasma. The company's key areas of expertise are high-quality, virus-inactivated medications for treating conditions such as hemophilia, immunology and intensive care medicine.
- 1983
- Established Company
- Onsite
- Pharmaceutical Sector, Chemical Industry, Biotech · Science, Research
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