Head of Quality Assurance | Pharmacist (m/w/d)
CatalYm GmbH
Job Summary
This leadership position requires overseeing all Quality Assurance activities within clinical development, focusing heavily on GxP-governed processes, particularly GMP and GCP, including Clinical Safety. The Head of QA will be instrumental in establishing and maintaining a robust Quality Management System (QMS), driving regulatory compliance, and cultivating a culture of continuous quality improvement. Key responsibilities include leading the QA department, developing risk-based quality management approaches, and managing internal and external audits across all GxP areas. The role also involves ensuring inspection readiness, serving as the primary contact for regulatory GxP inspections, and aligning quality initiatives with C-level executives. This role is ideal for a seasoned professional in life sciences or pharmacy with extensive experience in pharmaceutical/biotech QA who is fluent in English and possesses strong leadership capabilities.
Required Skills
Education
Advanced degree in life sciences, pharmacy, or medicine
Experience
- 10+ years in pharmaceutical/biotech industry
- At least 5 years in Quality Assurance or Compliance
- Professional experience in clinical development
- Experience in preparing for and managing regulatory inspections
- Strong leadership skills working in a matrix setting
Languages
Additional
- Flexibility for travel on an as needed basis
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