Head of Quality Strategy for Computerized Systems | Head of Quality Strategy for Computerized Systems (all genders)
Merck KGaA
Job Summary
This senior leadership role requires defining and executing the global Quality Strategy for Computerized Systems (CS) and Artificial Intelligence (AI) within the Healthcare R&D division. The Head of Quality Strategy is responsible for ensuring the integrity and compliance of quality management systems associated with these technologies, driving continuous improvement, and fostering a robust culture of quality across the organization. Key daily activities include directing the global Quality Strategy team, managing audits and inspections related to R&D CS and AI, and defining and executing GLP, GCP, and GVP compliant validation and lifecycle management strategies. The successful candidate must possess an advanced degree and extensive experience in GxP-regulated Quality Assurance, demonstrating deep knowledge of worldwide CS and AI regulatory requirements and the ability to collaborate with executives to resolve complex risk issues. This position offers the opportunity to shape compliance strategies for emerging technologies in drug development.
Required Skills
Education
Advanced degree (MSc or PhD) in Computerized Systems, Information Technology, or a related field, or a degree in Life Sciences combined with equivalent professional experience.
Experience
- Minimum 10 years in Quality Assurance or computerized system validation in a GxP-regulated environment
- At least 5 years managing global QA programs for computerized system compliance
- Proven ability to design and execute risk-based validation strategies for GxP systems
- Subject Matter Expert working knowledge in computerized systems validation
Languages
Additional
- Not specified
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