Global Quality Strategy Expert (m/f/d) - Data Analytics & AI
Core
Develop and implement global quality strategy, oversight models, and frameworks for Clinical Data Management, Governance, Analytics, Biostatistics, Digital Technologies, and AI-enabled systems within a pharmaceutical R&D environment.
Role type
Senior Quality Strategy Expert (Data Analytics & AI)
Builds
Quality assurance frameworks, risk-based analytics models, and AI governance controls for clinical development and operational processes.
Domain
Pharmaceutical R&D, Clinical Data Management, AI/ML Governance
Deliverable
production ML models
Required skills
GxP Quality Assurance and auditing, AI/ML system assessment, risk-based analytics, regulatory inspection support, stakeholder management, strategic planning, audit leadership, data integrity management, change management, mentorship
Preferred skills
German language proficiency
Technologies
Machine learning, Generative AI, Electronic Data Capture (EDC), Cloud-based technologies, Computerized systems
Responsibilities
Develop global quality strategy for AI and digital systems; Drive risk-based analytics to manage quality risks; Evaluate AI governance controls and model lifecycle management; Monitor evolving regulatory expectations for AI; Mentor QA auditors in digital/AI methodologies; Lead global GxP audits of CROs and technology vendors.
Seniority
Senior, strategic leadership with hands-on audit experience