Job
In diesem Job entwickelst du die globale Qualitätsstrategie für klinische Daten und digitale Technologien, führst Qualitätsbewertungen von KI-Anwendungen durch und unterstützt digitale Transformationsprojekte zur Sicherstellung von Datenintegrität.
Deine Rolle im 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 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).
Unsere Erwartungen an dich
Ausbildung
- Completed degree in Life Sciences, Statistics, Computer Science, Data Science, Quality Management, or related discipline.
Qualifikationen
- 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.
Erfahrung
- 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.
Unser Angebot
- 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.
Benefits
Essen & Trinken
Gesundheit, Fitness & Fun
Themen, mit denen du dich im Job beschäftigst
Job-Standorte
Das ist dein Arbeitgeber
Wien
Octapharma wurde bereits 1983 gegründet und spezialisierte sich von Anfang an auf die Entwicklung und Herstellung von Präparaten aus menschlichem Plasma. Heute stellen hochreine, virusinaktivierte Arzneimittel einen Schwerpunkt in den Bereichen Hämathologie, Immunologie und Intensivmedizin dar.
- 1983
- Etablierte Firma
- Onsite
- Pharma, Chemie, Biotech · Wissenschaft, Forschung
Weitere Jobs
Diese Jobs könnten dich auch interessieren
As a Data Engineer , you’ll play a key role in building modern, scalable, and high-performance data solutions on Google Cloud Platform (GCP) . You’ll be part of our growing Data & AI team, designing and implementing data architectures that help...
Du denkst in Architekturen statt in einzelnen Features? Du möchtest Kunden auf Augenhöhe beraten, technische Entscheidungen treffen und moderne Customer Engagement-, Service-, Power Platform- und AI-Lösungen gestalten? Dann bist du bei easyconsult...
Mitarbeit bei der Entwicklung und Weiterentwicklung unserer Softwareprodukte. Analyse von Anforderungen sowie Spezifikation, technisches Design und Umsetzung neuer und bestehender Lösungen. Aktive Mitarbeit im Spec-Driven-Development-Prozess von der...
